Trial Outcomes & Findings for Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD (NCT NCT02220985)
NCT ID: NCT02220985
Last Updated: 2026-06-01
Results Overview
Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Up to 5 years post-transplant
Results posted on
2026-06-01
Participant Flow
Participants were recruited based on referral for Hematopoietic Cell Transplant at Fred Hutchinson Cancer Center and University of Pittsburgh Medical Center between July 2014 and March 2020. The first participant enrolled on March 23, 2015 and the last participant enrolled on March 11, 2020.
Of the 84 enrolled participants, only 77 received naïve T-cell deplete grafts. 6 out of the 7 remaining participants received unmanipulated grafts, 5 because cell selection precluded inadequate donor CD34 cells, and 1 because cell selection was unsuccessful. The seventh participant switched to cord blood transplant because the donor became medically unavailable after the patient had begun conditioning. Characteristics and outcomes of these patients are in table S2 and S10 of JCO paper.
Participant milestones
| Measure |
Arm A (MRD / High Intensity Conditioning)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
18
|
18
|
|
Overall Study
Alive at Day 28 post transplant
|
20
|
20
|
18
|
18
|
|
Overall Study
Alive at Day 100 post transplant
|
20
|
20
|
17
|
18
|
|
Overall Study
Alive at 1 year post transplant
|
19
|
17
|
15
|
15
|
|
Overall Study
Alive at 2 years post transplant
|
18
|
16
|
15
|
14
|
|
Overall Study
Alive at 3 years post transplant
|
17
|
16
|
15
|
14
|
|
Overall Study
COMPLETED
|
16
|
16
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
4
|
4
|
Reasons for withdrawal
| Measure |
Arm A (MRD / High Intensity Conditioning)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Overall Study
Death
|
5
|
4
|
4
|
4
|
Baseline Characteristics
Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD
Baseline characteristics by cohort
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=21 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
6 Participants
n=201 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=24 Participants
|
20 Participants
n=24 Participants
|
14 Participants
n=48 Participants
|
17 Participants
n=100 Participants
|
71 Participants
n=201 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
12 Participants
n=48 Participants
|
13 Participants
n=100 Participants
|
49 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
5 Participants
n=100 Participants
|
28 Participants
n=201 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
3 Participants
n=100 Participants
|
6 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=24 Participants
|
18 Participants
n=24 Participants
|
17 Participants
n=48 Participants
|
15 Participants
n=100 Participants
|
67 Participants
n=201 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=201 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=48 Participants
|
1 Participants
n=100 Participants
|
8 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=24 Participants
|
19 Participants
n=24 Participants
|
16 Participants
n=48 Participants
|
17 Participants
n=100 Participants
|
69 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=201 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post-transplantPopulation: Participants who received Naive T cell depleted PBSCT and were alive at Day 100 post-transplant were analyzed.
Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression.
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=17 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Chronic GVHD
Moderate Chronic GVHD (requiring systemic corticosteroids)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Chronic GVHD
Severe Chronic GVHD (requiring systemic corticosteroids)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chronic GVHD
No chronic GVHD
|
17 Participants
|
20 Participants
|
14 Participants
|
17 Participants
|
|
Chronic GVHD
Mild Chronic GVHD not requiring systemic corticosteroids
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Chronic GVHD
Mild Chronic GVHD requiring systemic corticosteroids
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post-transplantPopulation: Participants who received NTCD PBSC transplant and were alive at day 28 post-transplant
Measure the number of days to discontinuation of prednisone in recipients of CD45RA+ T cell-depleted PBSCT by arm. Possible outcomes range from no systemic immunosuppression (best outcome) to 5 years on immunosuppression (poor outcome)
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Time to Completion of Prednisone
|
65 Days post transplant
Standard Deviation 84
|
68 Days post transplant
Standard Deviation 98
|
87 Days post transplant
Standard Deviation 110
|
79 Days post transplant
Standard Deviation 332
|
PRIMARY outcome
Timeframe: Up to 5 years post-transplantPopulation: Participants who received NTCD PBSC transplant and were alive at day 28 post-transplant
Measure the number of days to discontinuation of all immunosuppression in recipients of CD45RA+ T cell-depleted PBSCT by arm. Possible outcomes range from no systemic immunosuppression (best outcome) to 5 years on immunosuppression (poor outcome)
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Time to Completion of All Immunosuppression
|
252 Days
Standard Deviation 99
|
216 Days
Standard Deviation 165
|
244 Days
Standard Deviation 145
|
223 Days
Standard Deviation 317
|
PRIMARY outcome
Timeframe: At 2 years post transplantPopulation: Participants who received NTCD PBSC and were alive at 2 years
Number of patients requiring immunosuppression 2 years after transplant.
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=16 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=15 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=14 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Requirement of Immunosuppression at 2 Years After Transplant
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Through day 100 post-transplantPopulation: Participants who received Naive T Cell Depleted PBSC and were alive at day 100 post-transplant
Presence of acute graft-versus-host disease (GVHD) grades II-IV, defined operationally as the occurrence of compatible symptoms or signs in the skin, gastrointestinal tract, or liver, in patients who received Naive t cell depleted PBSCT. Staging and grading are found on page 8 of the JCO supplement (Bleakley et al., 2022, original references Glucksberg et all, 1974, Przepiorka et all, 1995 ) with higher grade indicating worse outcomes.
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=17 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Acute GVHD
No acute GVHD
|
5 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Acute GVHD
Grade II acute GVHD
|
15 Participants
|
14 Participants
|
13 Participants
|
15 Participants
|
|
Acute GVHD
Grade III acute GVHD
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Acute GVHD
Grade IV acute GVHD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post-transplantPopulation: Participants who received a Naive T Cell depleted PBSCT and who were alive at day 28 post-transplant
Defined operationally as failure to reach an absolute neutrophil count (ANC) of \> 500/ul for 3 consecutive days by day 28 or irreversible decrease in ANC to \< 100 after an established donor graft.
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Graft Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through day 100 post-transplantPopulation: All participants who received a NTCD PBSC transplant
Defined as mortality in any patient for whom there has not been a diagnosis of relapse.
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=21 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Transplant Related Mortality by Day 100
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post-transplantPopulation: All participants who received a Naive T cell deplete transplant
Defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology.
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=21 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Relapse
|
3 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsUse of additional immune suppressive agents other than first line therapy (prednisone and tacrolimus/cyclosporine)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to day 100Requirement for secondary systemic therapy for acute graft-versus-host disease (GVHD) management
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through day 100 post-transplantPopulation: Participants who received NTCD PBSC and were alive at day 28 post-transplant
Time to absolute neutrophil count (ANC) of \> 500/uL on the first of three consecutive days
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Engraftment - ANC >500/uL
|
17.5 Days
Standard Deviation 2.8
|
14.5 Days
Standard Deviation 2.1
|
15.5 Days
Standard Deviation 2.6
|
15.5 Days
Standard Deviation 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through Day 100 post-transplantPopulation: Participants who received NTCD PBSC transplant and were alive at day 28 post-transplant
Time to absolute neutrophil count (ANC) of \> 1,000/uL on the first of three consecutive test results
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Engraftment - ANC <1,000/uL
|
19 Days
Standard Deviation 5.5
|
15.5 Days
Standard Deviation 2.6
|
18 Days
Standard Deviation 3.2
|
16.5 Days
Standard Deviation 4.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through day 100 post-transplantPopulation: Participants who received NTCD PBSC and were alive at Day 100 post-transplant
Time to platelet count \> 20,000/uL for 3 days without transfusion
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=17 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Platelet Engraftment
|
15.5 Days post transplant
Standard Deviation 4
|
13.5 Days post transplant
Standard Deviation 1.8
|
15.35 Days post transplant
Standard Deviation 3.25
|
13 Days post transplant
Standard Deviation 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through day 100 post-transplantPopulation: Participants who received NTCD PBSC and were alive at Day 100 post-transplant
Time to platelet count \> 50,000/uL for 3 days without transfusion
Outcome measures
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=20 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=17 Participants
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 Participants
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Platelet Engraftment - 50,000/uL
|
22 Days post transplant
Standard Deviation 4.1
|
17 Days post transplant
Standard Deviation 2
|
20 Days post transplant
Standard Deviation 3.7
|
16 Days post transplant
Standard Deviation 4.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 360 daysWill be analyzed from peripheral blood or marrow.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (MRD / High Intensity Conditioning)
Serious events: 21 serious events
Other events: 6 other events
Deaths: 5 deaths
Arm B (MRD / Low Intensity Conditioning)
Serious events: 17 serious events
Other events: 8 other events
Deaths: 4 deaths
Arm C (MUD / High Intensity Conditioning)
Serious events: 18 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm D (MUD / Low Intensity Conditioning)
Serious events: 15 serious events
Other events: 8 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=21 participants at risk
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 participants at risk
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 participants at risk
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 participants at risk
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Cardiac disorders
Heart Failure
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
16.7%
3/18 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Mucositis oral
|
81.0%
17/21 • Number of events 17 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
20.0%
4/20 • Number of events 4 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
100.0%
18/18 • Number of events 18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
44.4%
8/18 • Number of events 8 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
25.0%
5/20 • Number of events 5 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
22.2%
4/18 • Number of events 5 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Typhlitis
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
General disorders
Pain
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Anorectal infection
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Catheter related infection
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Enterocolitis
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Infections and infestations - Other
|
85.7%
18/21 • Number of events 27 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
60.0%
12/20 • Number of events 22 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
55.6%
10/18 • Number of events 14 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
50.0%
9/18 • Number of events 14 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Lung Infection
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Sepsis
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Skin infection
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Investigations
Weight loss investigations
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
15.0%
3/20 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.8%
5/21 • Number of events 5 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.5%
2/21 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
2/21 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.5%
2/21 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Nervous system disorders
Arachnoiditis
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Psychiatric disorders
Mania
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Skin and subcutaneous tissue disorders
Rash, maculo-papular
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
16.7%
3/18 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
Other adverse events
| Measure |
Arm A (MRD / High Intensity Conditioning)
n=21 participants at risk
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm B (MRD / Low Intensity Conditioning)
n=20 participants at risk
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
Arm C (MUD / High Intensity Conditioning)
n=18 participants at risk
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
|
Arm D (MUD / Low Intensity Conditioning)
n=18 participants at risk
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1.
TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0.
GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
|
|---|---|---|---|---|
|
Infections and infestations
Infections and infestations, other
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
15.0%
3/20 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.5%
2/21 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.0%
1/20 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/18 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
1/21 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Nervous system disorders
Syncope
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
10.0%
2/20 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/21 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
16.7%
3/18 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
5.6%
1/18 • Number of events 1 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
0.00%
0/20 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
11.1%
2/18 • Number of events 2 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
16.7%
3/18 • Number of events 3 • Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Only grades 3-5 non-hematologic adverse events were captured.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place