Trial Outcomes & Findings for Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies (NCT NCT01427881)

Results Overview

Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

At 1 year after transplantation

Results posted on

2017-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Overall Study STARTED	43
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Age, Continuous	38 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 year after transplantation

Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Chronic GVHD Requiring Systemic Immunosuppressive Treatment	16 percent of patients Interval 5.0 to 28.0

SECONDARY outcome

Timeframe: At day 28

Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Donor Engraftment	6 Participants

SECONDARY outcome

Timeframe: Through day +100 post-transplant

Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Grades II-IV and III-IV Acute GVHD Grades II-IV GVHD	77 percentage of patients
Grades II-IV and III-IV Acute GVHD Grades III-IV GVHD	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 5 years

Population: This data was not collected.

The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years

Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Persistent or Recurrent Malignancy After HCT	17 percentage of patients Interval 5.0 to 29.0

SECONDARY outcome

Timeframe: At 2 years

Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Non-relapse Mortality	14 percentage of patients Interval 4.0 to 25.0

SECONDARY outcome

Timeframe: At 1 year post-transplant

Overall survival will be evaluated as Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Overall Survival	75.6 percentage of patients Interval 63.5 to 90.1

SECONDARY outcome

Timeframe: At 1 year post-transplant

Disease-free survival will be evaluated as Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Disease-free Survival	73.8 percentage of patients Interval 61.6 to 88.5

SECONDARY outcome

Timeframe: Up to day +100

Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is \> 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is \>= 20,000/uL without platelet transfusion support in the seven days prior.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Hematologic Recovery Neutrophil Engraftment	19 days Interval 16.0 to 37.0
Hematologic Recovery Platelet Engraftment	14 days Interval 10.0 to 47.0

SECONDARY outcome

Timeframe: By greater than or equal to 28 days post-transplant

Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of \>= 500/uL by \>= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to \< 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.

Outcome measures

Outcome measures
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 Participants PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Graft Failure	2 percentage of patients

Adverse Events

Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)

Serious events: 22 serious events

Other events: 40 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 participants at risk PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Blood and lymphatic system disorders Infection/Fever	30.2% 13/43 • Number of events 18 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Blood and lymphatic system disorders Disease recurrence/MRD	9.3% 4/43 • Number of events 4 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Cardiac disorders Bradycardia	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Blood and lymphatic system disorders Delayed engraftment	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Blood and lymphatic system disorders Graft failure/poor graft function	100.0% 1/1 • Number of events 2 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Musculoskeletal and connective tissue disorders Pain	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Cardiac disorders Pericardial effusion	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Immune system disorders GVHD	14.0% 6/43 • Number of events 7 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Respiratory, thoracic and mediastinal disorders Respiratory (not infection)	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Musculoskeletal and connective tissue disorders Myositis	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Nervous system disorders Headache	4.7% 2/43 • Number of events 2 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Musculoskeletal and connective tissue disorders RS3PE (rheumatologic)	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Vascular disorders Orthastic hypotension	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Gastrointestinal disorders Cholecystitis	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Nervous system disorders Syncope	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center

Other adverse events

Other adverse events
Measure	Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) n=43 participants at risk PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
Blood and lymphatic system disorders Failure to engraft by day 28	7.0% 3/43 • Number of events 3 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Gastrointestinal disorders Persistent n/v thru day 28 and not related to GVHD	7.0% 3/43 • Number of events 3 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Cardiac disorders Heart failure or LV dysfunction (grade 3-5)	0.00% 0/43 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Gastrointestinal disorders Mucositis (grade 3-5; requiring TPN)	93.0% 40/43 • Number of events 40 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
Renal and urinary disorders Cystitis or hematuria (grade 2-5; not infection)	2.3% 1/43 • Number of events 1 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
General disorders Other (grade 3-5)	0.00% 0/43 • For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center

Additional Information

Marco Mielcarek, MD

Fred Hutchinson Cancer Research Center

Phone: 206-667-2827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place