Trial Outcomes & Findings for Crohn's Allogeneic Transplant Study (NCT NCT01570348)
NCT ID: NCT01570348
Last Updated: 2020-02-17
Results Overview
Defined as alive and free of active CD. Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
At 1 year post-transplant
Results posted on
2020-02-17
Participant Flow
Participants were recruited 7/2012 and 8/2015 via website (www.CATS-FHCRC.org). Over 700 completed questionnaires, \>150 were deemed potentially eligible. 15 completed records reviewed and invited for in-depth screening for eligibility. Two study participants were enrolled.
Participant milestones
| Measure |
Treatment (Allogeneic BMT)
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Crohn's Allogeneic Transplant Study
Baseline characteristics by cohort
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 1 year post-transplantDefined as alive and free of active CD. Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Event-free Survival (EFS)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Development of Infectious Complications
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsEvaluated using a standardized tool for evaluating CD (CDAI).
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Disease Activity
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years post-transplantDescribed graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
EFS
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe grading of acute and chronic GVHD will follow previously published guidelines but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and CD involve the gastrointestinal tract, all diagnostic biopsies of these organs will be reviewed by pathologists experienced in the diagnosis of GVHD and IBD, respectively.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Incidence and Severity of GVHD
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsIncludes the administration of any therapy (drugs, biologics, or any other treatments) clearly given as immunomodulatory therapy for underlying CD.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Incidence of Disease-modifying Drugs for CD Initiated Post-transplant
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsEngraftment is defined as achieving \> 5% donor peripheral blood CD3 T cell chimerism by day 84 after HCT. Primary graft failure is defined as a donor peripheral blood CD3 T cell chimerism peak of \< 5% by Day 84 post-HCT. Secondary graft failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood CD3 T cell chimerism \< 5% as demonstrated by a chimerism assay.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Incidence of Graft Rejection
|
0 Participants
|
SECONDARY outcome
Timeframe: Time of treatment assignment until death due to any cause, assessed up to 5 yearsCharacterized by the event rates as functions of all patients enrolled and at risk of the event, with exact confidence intervals.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Survival
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year post-BMTCharacterized by the rates of reportable events as functions of all patients enrolled and at risk of the event, with exact confidence intervals. With the exception of adverse events (AEs) that are universal and expected following conditioning therapy, all reportable AEs will be tabulated for each patient from the time that the subject starts mobilization of hematopoietic cells until day +365 after transplant.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Regimen-related Toxicity Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
|
1 Participants
|
SECONDARY outcome
Timeframe: Time from BMT to death definitely or probably resulting from treatment, assessed up to 5 yearsA stopping rule will be imposed for TRM occurring within one year of transplant. The study will be stopped if at any point there is moderately strong evidence that the rate of TRM exceeds 10%. Moderately strong evidence will be taken to mean that the lower bound of a one-sided 80% confidence interval for the true rate of TRM is above 10%.
Outcome measures
| Measure |
Treatment (Allogeneic BMT)
n=2 Participants
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Treatment-related Mortality (TRM)
|
1 Participants
|
Adverse Events
Treatment (Allogeneic BMT)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Allogeneic BMT)
n=2 participants at risk
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
Other adverse events
| Measure |
Treatment (Allogeneic BMT)
n=2 participants at risk
CONDITIONING THERAPY: Patients receive fludarabine phosphate IV over 30-60 minutes QD on days -6 to -2 and cyclophosphamide IV over 1-2 hours QD on days -6 and -5. Patients undergo total body irradiation on day -1.
TRANSPLANTATION: Patients undergo donor BMT on day 0.
IMMUNOSUPPRESSIVE THERAPY: Patients receive high-dose cyclophosphamide IV over 1-2 hours QD on days 3-4, tacrolimus IV daily or PO BID on days 5-180 with taper to day 365, and mycophenolate acid enteric coated or mycophenolate mofetil PO TID on days 0-35.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Mycophenolate Mofetil: Given PO
Mycophenolic Acid: Given PO
Quality-of-Life Assessment: Ancillary studies
Tacrolimus: Given IV or PO
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Vascular disorders
thromboembolotic event
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Infections and infestations
CMV Reactivation
|
50.0%
1/2 • Number of events 2 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Injury, poisoning and procedural complications
Femoral neck stress fracture
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Respiratory, thoracic and mediastinal disorders
metapneumovirus pneumonia
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratoroy failure
|
50.0%
1/2 • Number of events 3 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Renal and urinary disorders
acute kidney injury
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
|
Gastrointestinal disorders
GI bleed/dirrhea
|
50.0%
1/2 • Number of events 1 • Adverse events collected from mobilization start until day +365 after allogeneic HCT or patient withdraws from the study. After HCT- day +100, grades 3, 4 and 5 adverse events will be captured, exception outlined in Appendix J. Grades 3 and 4 adverse events in CD involved organs only if they represent a significant change from baseline status. Day+100- +365 only Grades 4 and 5.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place