Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With Myeloid Cancer or Other Disease (NCT NCT00392782)
NCT ID: NCT00392782
Last Updated: 2017-12-28
Results Overview
Number of patients alive and without disease at 1 year after transplant.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
1 Year
Results posted on
2017-12-28
Participant Flow
Participant milestones
| Measure |
All Treated Patients
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplant in Treating Patients With Myeloid Cancer or Other Disease
Baseline characteristics by cohort
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Disease
Acute Myeloid Leukemia - CR1
|
10 Participants
n=5 Participants
|
|
Disease
Acute Myeloid Leukemia - CR2
|
7 Participants
n=5 Participants
|
|
Disease
Myelodysplastic Syndrome - RAEB2
|
2 Participants
n=5 Participants
|
|
Disease
Myelodysplastic Syndrome - NOS
|
1 Participants
n=5 Participants
|
|
Disease
Chronic Myeloid Leukemia
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearNumber of patients alive and without disease at 1 year after transplant.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Incidence of Disease-free Survival
|
18 Participants
|
SECONDARY outcome
Timeframe: 1 YearNumber of patients with disease at 1 year.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Incidence of Disease Relapse
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 100Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 YearNumber of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Incidence of Chronic Graft-versus-host Disease (GVHD)
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 100Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Incidence of Graft Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 YearNumber of patients with treatment related death at 1 year post transplant.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Transplant-related Mortality
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 YearNumber of patients who were deceased at 1 year post transplant.
Outcome measures
| Measure |
All Treated Patients
n=24 Participants
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Overall Survival
|
10 Participants
|
Adverse Events
All Treated Patients
Serious events: 23 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Treated Patients
n=24 participants at risk
Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.
Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
|
|---|---|
|
Immune system disorders
ALT/serum glutamic pyruvic transaminase increased
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Blood and lymphatic system disorders
Blood/bone marrow, other
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Nervous system disorders
Cerebrovascular ischemia
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Cardiac disorders
Cardiac, general
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
General disorders
Death
|
12.5%
3/24 • Number of events 3 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Gastrointestinal disorders
Dehydration
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
4/24 • Number of events 4 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
General disorders
Fatigue
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Endocrine disorders
Low serum glucose
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Blood and lymphatic system disorders
Infection with Grade 3-4 neutrophils
|
4.2%
1/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection, other
|
12.5%
3/24 • Number of events 4 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection with normal neutrophils, lung
|
4.2%
1/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection with unknown neutrophils, blood
|
25.0%
6/24 • Number of events 6 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection with unknown neutrophils, catheter
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection with unknown neutrophils, colon
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection w/unknown neutrophils - lung
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection w/unknown neutrophils - mucosa
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection with unknown neutrophils - upper airway
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Infections and infestations
Infection with unknown neutrophils - wound
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Gastrointestinal disorders
Mucositis
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
General disorders
Gastrointestinal necrosis
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Nervous system disorders
Neurology
|
4.2%
1/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction - ureter
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
General disorders
Pain - abdomen
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Cardiac disorders
Pain - cardiac/heart
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
General disorders
Progressive disease
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - upper respiratory
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
General disorders
Relapse
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Renal and urinary disorders
Renal
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Nervous system disorders
Syncope
|
4.2%
1/24 • Number of events 1 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Blood and lymphatic system disorders
Thrombosis
|
8.3%
2/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
|
Cardiac disorders
Vascular
|
4.2%
1/24 • Number of events 2 • Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
|
Other adverse events
Adverse event data not reported
Additional Information
Daniel Weisdorf, M.D.
Masonic Cancer Center, University of Minnesota
Phone: 612-624-0123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place