Trial Outcomes & Findings for Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603) (NCT NCT00849147)
NCT ID: NCT00849147
Last Updated: 2023-01-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Measured at Month 6 and Year 1
Results posted on
2023-01-04
Participant Flow
Participant milestones
| Measure |
Haplo-marrow Transplantation
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Haplo-marrow Transplantation
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Disease Relapse/Progression
|
2
|
Baseline Characteristics
Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
Baseline characteristics by cohort
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Karnofsky Performance-status score
100%
|
19 participants
n=5 Participants
|
|
Karnofsky Performance-status score
90%
|
19 participants
n=5 Participants
|
|
Karnofsky Performance-status score
80%
|
9 participants
n=5 Participants
|
|
Karnofsky Performance-status score
70%
|
3 participants
n=5 Participants
|
|
Primary Disease
Acute Lymphoblastic Leukemia
|
6 participants
n=5 Participants
|
|
Primary Disease
Acute Myelogeneous Leukemia
|
22 participants
n=5 Participants
|
|
Primary Disease
Biphenotypic/Undifferentiated Leukemia
|
3 participants
n=5 Participants
|
|
Primary Disease
Hodgkins Lymphoma
|
7 participants
n=5 Participants
|
|
Primary Disease
Large Cell Lymphoma
|
8 participants
n=5 Participants
|
|
Primary Disease
Marginal Zone B-cell Lymphoma
|
1 participants
n=5 Participants
|
|
Primary Disease
Mantle Cell Lymphoma
|
3 participants
n=5 Participants
|
|
Human leucocyte antigen (HLA) Typing Match Score - GVH direction
5/10
|
28 participants
n=5 Participants
|
|
Human leucocyte antigen (HLA) Typing Match Score - GVH direction
6/10
|
12 participants
n=5 Participants
|
|
Human leucocyte antigen (HLA) Typing Match Score - GVH direction
7/10
|
9 participants
n=5 Participants
|
|
Human leucocyte antigen (HLA) Typing Match Score - GVH direction
8/10
|
1 participants
n=5 Participants
|
|
HLA Typing Match Score - Host vs Graft (HVG) direction
5/10
|
22 participants
n=5 Participants
|
|
HLA Typing Match Score - Host vs Graft (HVG) direction
6/10
|
22 participants
n=5 Participants
|
|
HLA Typing Match Score - Host vs Graft (HVG) direction
7/10
|
3 participants
n=5 Participants
|
|
HLA Typing Match Score - Host vs Graft (HVG) direction
8/10
|
1 participants
n=5 Participants
|
|
HLA Typing Match Score - Host vs Graft (HVG) direction
9/10
|
1 participants
n=5 Participants
|
|
HLA Typing Match Score - Host vs Graft (HVG) direction
10/10
|
1 participants
n=5 Participants
|
|
Weight
|
78 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6 and Year 1Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Overall Survival at 180 Days From the Time of Transplant
6 months
|
83.7 percentage of participants
Interval 70.0 to 91.5
|
|
Overall Survival at 180 Days From the Time of Transplant
1 year
|
62.0 percentage of participants
Interval 44.1 to 75.7
|
SECONDARY outcome
Timeframe: Measured at Days 28, 56, 90, and 100Cumulative incidence of neutrophil recovery \>500/μL at day +56
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Neutrophil Recovery
Day 28
|
96.0 percentage of participants
Interval 89.9 to 100.0
|
|
Neutrophil Recovery
Day 56
|
96.0 percentage of participants
Interval 89.9 to 100.0
|
|
Neutrophil Recovery
Day 90
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
|
Neutrophil Recovery
Day 100
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
SECONDARY outcome
Timeframe: Measured at Day 67Primary graft failure is defined as \< 5% donor chimerism on all measurements.
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Primary Graft Failure
|
1 participants
|
SECONDARY outcome
Timeframe: Measured at Day 100Secondary graft failure is defined as initial recovery followed by neutropenia with \< 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is \< 500/mm3, then it will be counted as a secondary graft failure.
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Secondary Graft Failure
|
0 participants
|
SECONDARY outcome
Timeframe: Measured at Days 56, 90, and 100Platelet Recovery to 20K
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Platelet Recovery
Day 56
|
96.0 percentage of participants
Interval 89.7 to 100.0
|
|
Platelet Recovery
Day 90
|
96.0 percentage of participants
Interval 89.7 to 100.0
|
|
Platelet Recovery
Day 100
|
98.0 percentage of participants
Interval 93.1 to 100.0
|
SECONDARY outcome
Timeframe: Measured at Days 56, 90, and 100Platelet Recovery to 50K
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Platelet Recovery
Day 90
|
76.0 percentage of participants
Interval 63.8 to 88.2
|
|
Platelet Recovery
Day 100
|
76.0 percentage of participants
Interval 63.8 to 88.2
|
|
Platelet Recovery
Day 56
|
76.0 percentage of participants
Interval 63.8 to 88.2
|
SECONDARY outcome
Timeframe: Measured at Day 56Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days \~28, \~56, \~180, and \~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Donor Cell Engraftment
Chimerism Performed
|
42 participants
|
|
Donor Cell Engraftment
Donor Percentage ≥95%
|
39 participants
|
|
Donor Cell Engraftment
Donor Percentage 5%-95%
|
2 participants
|
|
Donor Cell Engraftment
Donor Percentage <5%
|
1 participants
|
SECONDARY outcome
Timeframe: Measured at Day 100Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Acute Graft-versus-host Disease (GVHD)
Grade II-IV Acute GVHD
|
32.0 percentage of participants
Interval 18.9 to 45.1
|
|
Acute Graft-versus-host Disease (GVHD)
Grade III-IV Acute GVHD
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Measured at Year 1Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Chronic GVHD
|
12.9 percentage of participants
Interval 2.9 to 22.9
|
SECONDARY outcome
Timeframe: Measured at Year 1Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Progression-free Survival
|
47.9 percentage of participants
Interval 32.0 to 62.2
|
SECONDARY outcome
Timeframe: Measured at 6 months and 1 yearOutcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Treatment-related Mortality (TRM)
6 months
|
4.0 percentage of participants
Interval 0.0 to 9.5
|
|
Treatment-related Mortality (TRM)
1 year
|
7.0 percentage of participants
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: 36 patients incurred a total number of 108 infection events.
Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.
Outcome measures
| Measure |
Haplo-marrow Transplantation
n=50 Participants
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Infections
1 Infection
|
14 participants
|
|
Infections
2 Infections
|
6 participants
|
|
Infections
3 Infections
|
10 participants
|
|
Infections
4 Infections
|
2 participants
|
|
Infections
5 Infections
|
1 participants
|
|
Infections
6-10 Infections
|
2 participants
|
|
Infections
>10 Infections
|
1 participants
|
Adverse Events
Haplo-marrow Transplantation
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Haplo-marrow Transplantation
n=52 participants at risk
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/52 • Number of events 1 • 1-year post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
1/52 • Number of events 1 • 1-year post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
|
Infections and infestations
Pseudomonas infection
|
1.9%
1/52 • Number of events 1 • 1-year post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.9%
1/52 • Number of events 1 • 1-year post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/52 • Number of events 1 • 1-year post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
Other adverse events
| Measure |
Haplo-marrow Transplantation
n=52 participants at risk
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
|
|---|---|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • 1-year post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place