Trial Outcomes & Findings for Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia (NCT NCT01904136)
NCT ID: NCT01904136
Last Updated: 2024-01-24
Results Overview
Number of participants that experienced dose limiting toxicities.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Up to day 70 post-transplant
Results posted on
2024-01-24
Participant Flow
Participants were recruited at MD Anderson Cancer Center from April 2014 until June 2019.
Total number of participants registered in MDACC was 54, which 27 participants were Donors (Signed consent but not involved in results outcome and no Adverse events were collected) and 27 were Recipients (Treated with donor NK cells).
Participant milestones
| Measure |
Phase I: NK Cell Dose Level 1_10^4
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 6_10^8
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
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|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
|
1
|
2
|
3
|
3
|
2
|
3
|
3
|
10
|
27
|
|
Overall Study
COMPLETED
|
1
|
2
|
3
|
3
|
2
|
2
|
3
|
10
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I: NK Cell Dose Level 1_10^4
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
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Phase II: NK Cell Dose Level 5_3x10^7
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 6_10^8
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT
Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
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|---|---|---|---|---|---|---|---|---|---|
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Overall Study
Physician Decision
|
0
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0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
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Baseline Characteristics
Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Phase I: NK Cell Dose Level 1_10^4
n=1 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90. Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8 Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90. Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8 Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90. Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8 Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90. Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8 Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90. Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8 Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90. Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 6_10^8
n=10 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Donor
n=27 Participants
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
24 Participants
n=114 Participants
|
50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
25 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
16 Participants
n=114 Participants
|
29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
24 Participants
n=114 Participants
|
48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
2 participants
n=31 Participants
|
2 participants
n=30 Participants
|
3 participants
n=3 Participants
|
10 participants
n=6 Participants
|
27 participants
n=114 Participants
|
53 participants
|
|
Region of Enrollment
Iran
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
0 participants
n=3 Participants
|
0 participants
n=6 Participants
|
0 participants
n=114 Participants
|
1 participants
|
PRIMARY outcome
Timeframe: Up to day 70 post-transplantPopulation: Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
Number of participants that experienced dose limiting toxicities.
Outcome measures
| Measure |
Phase I: NK Cell Dose Level 1_10^4
n=1 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Phase II: NK Cell Dose Level 6_10^8
n=10 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantPopulation: Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
Number of participants who died within 100 days post-transplant.
Outcome measures
| Measure |
Phase I: NK Cell Dose Level 1_10^4
n=1 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Phase II: NK Cell Dose Level 6_10^8
n=10 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
|
|---|---|---|---|---|---|---|---|---|---|
|
100-day Treatment Related Mortality
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
Number of participants with overall survival after 2 years.
Outcome measures
| Measure |
Phase I: NK Cell Dose Level 1_10^4
n=1 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
n=2 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
n=3 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Phase II: NK Cell Dose Level 6_10^8
n=10 Participants
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
Adverse Events
Phase I: NK Cell Dose Level 1_10^4
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I: NK Cell Dose Level 2_10^5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase I: NK Cell Dose Level 3_10^6
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I: NK Cell Dose Level 4_ 10^7
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: NK Cell Dose Level 5_3x10^7
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I: NK Cell Dose Level 6_10^8
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase II: NK Cell Dose Level 5_3x10^7
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase II: NK Cell Dose Level 6_10^8
Serious events: 6 serious events
Other events: 10 other events
Deaths: 5 deaths
Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: NK Cell Dose Level 1_10^4
n=1 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
n=2 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
n=3 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
n=3 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
n=2 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
n=2 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
n=3 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Phase II: NK Cell Dose Level 6_10^8
n=10 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Secondary graft failure
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Infections and infestations
Viral Infections
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Infections and infestations
Bacterial Infections
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
GI GvHD
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Blood and lymphatic system disorders
Delayed engraftment
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Hepatobiliary disorders
Liver GvHD
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Blood and lymphatic system disorders
CNS hemorrahge due to DSA/PLT Refractory
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
Other adverse events
| Measure |
Phase I: NK Cell Dose Level 1_10^4
n=1 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 2_10^5
n=2 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 3_10^6
n=3 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 4_ 10^7
n=3 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 5_3x10^7
n=2 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase I: NK Cell Dose Level 6_10^8
n=2 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 1: 1xE4 Cohort 2: 1xE5 Cohort 3: 1xE6 Cohort 4: 1xE7 Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer Cell Therapy: Given IV Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Tacrolimus: Given IV and PO Total-Body Irradiation: Undergo TBI
|
Phase II: NK Cell Dose Level 5_3x10^7
n=3 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Phase II: NK Cell Dose Level 6_10^8
n=10 participants at risk
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive high-dose melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and NK cells IV over 30 minutes on day -2 or -1.
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive melphalan IV over 30 minutes on day -7, fludarabine IV over 1 hour on days -7 to -4, undergo TBI on day -3, and receive NK cells IV over 30 minutes on day -2 or -1.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
POST-TRANSPLANT CYCLOPHOSPHAMIDE AND GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus IV beginning on day 5 for 2 weeks and then PO for approximately 4 months, and mycophenolate mofetil PO TID beginning on day 5 for approximately 6-7 months.
NK CELLS: Patients receive NK cells IV over 30 minutes on days 7 and 28-90.
Cohort 5: 3xE7 Cohort 6: 1xE8
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BMT Cyclophosphamide: Given IV Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Natural Killer
|
Donor
KIR mismatched haplo donors, KIR mismatched cord blood donors or HLA matched related donors.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bacterial Infections
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
5/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
General disorders
Flu like syndrome
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Blood and lymphatic system disorders
Neutropenic fevers
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
10/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
10/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
10/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
5/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Infections and infestations
Viral Infections
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
10/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
General disorders
Fevers
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
30.0%
3/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
General disorders
Fluid overload
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
70.0%
7/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Skin and subcutaneous tissue disorders
Skin GvHD
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
3/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
40.0%
4/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
GI GvHD
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
30.0%
3/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Investigations
Elevated bilirubin
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
30.0%
3/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Infections and infestations
Fungal Infections
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
20.0%
2/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Blood and lymphatic system disorders
HSCT related microangiopathy (TA-TMA)
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Investigations
Liver GvHD
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
Upper GI GvHD
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
5/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
30.0%
3/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
70.0%
7/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Infections and infestations
BK virus associated hemorrhagic cystitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
5/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Investigations
Elevated transminitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
66.7%
2/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
60.0%
6/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
20.0%
2/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
30.0%
3/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Gastrointestinal disorders
Neutropenic enterocolitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Renal and urinary disorders
Cytoxan induced Hemorrhagic Cystitis
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
50.0%
1/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
100.0%
2/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
33.3%
1/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/2 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
0.00%
0/3 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
10.0%
1/10 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
—
0/0 • Up to 2 years.
Twenty seven donor participants only signed consents and were not part of the results outcome and Adverse events were not collected.
|
Additional Information
UT MD Anderson Cancer Center
Samer Srour, MD / Stem Cellular Transplantation Department
Phone: 713-794-4354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place