Trial Outcomes & Findings for Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies (NCT NCT00741455)
NCT ID: NCT00741455
Last Updated: 2020-11-23
Results Overview
Rates of successful engraftment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Within 30 days of bone marrow transplant
Results posted on
2020-11-23
Participant Flow
Participant milestones
| Measure |
Study Treatment
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient.
Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.
Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
G-CSF: 10 mcg/k
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Treatment
n=18 Participants
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient.
Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.
Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
G-CSF: 10 mcg/k
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
57 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of bone marrow transplantRates of successful engraftment.
Outcome measures
| Measure |
Study Treatment
n=17 Participants
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient.
Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.
Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
G-CSF: 10 mcg/k
|
|---|---|
|
Number of Participants With Successful Bone Marrow Engraftment
Engrafted </= 15 Days
|
1 Participants
|
|
Number of Participants With Successful Bone Marrow Engraftment
Engrafted 16-30 Days
|
15 Participants
|
|
Number of Participants With Successful Bone Marrow Engraftment
Engrafted >30 Days
|
1 Participants
|
SECONDARY outcome
Timeframe: Post-transplant days +30, +60, +100, +180 and +365Complete donor chimerism
Outcome measures
| Measure |
Study Treatment
n=17 Participants
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient.
Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.
Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
G-CSF: 10 mcg/k
|
|---|---|
|
Number of Participants Who Achieve Complete Donor Chimerism
Complete Chimerism 30 Days Post Transplant
|
2 Participants
|
|
Number of Participants Who Achieve Complete Donor Chimerism
Complete Chimerism 60 Days Post Transplant
|
2 Participants
|
|
Number of Participants Who Achieve Complete Donor Chimerism
Complete Chimerism 100 Days Post Transplant
|
3 Participants
|
|
Number of Participants Who Achieve Complete Donor Chimerism
Complete Chimerism 180 Days Post Transplant
|
3 Participants
|
|
Number of Participants Who Achieve Complete Donor Chimerism
Complete Chimerism 365 Days Post Transplant
|
4 Participants
|
|
Number of Participants Who Achieve Complete Donor Chimerism
Chimerism Unknown
|
1 Participants
|
|
Number of Participants Who Achieve Complete Donor Chimerism
Did not achieve complete donor chimerism
|
2 Participants
|
SECONDARY outcome
Timeframe: Post-transplant procedure through deathPopulation: Data was not collected for this outcome measure
Collect the number of incidents of acute and chronic graft-versus-host disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 Years Post-TransplantMortality rates in subjects after successful completion of a bone marrow transplant
Outcome measures
| Measure |
Study Treatment
n=17 Participants
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient.
Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later.
Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml.
G-CSF: 10 mcg/k
|
|---|---|
|
Overall Survival Measured in Participants
Survival 5 to < 10 years post-transplant
|
0 Participants
|
|
Overall Survival Measured in Participants
Survival 10+ years post-transplant
|
7 Participants
|
|
Overall Survival Measured in Participants
Survival < 1 year post-transplant
|
2 Participants
|
|
Overall Survival Measured in Participants
Survival 1 to < 5 years post-transplant
|
8 Participants
|
SECONDARY outcome
Timeframe: Until the 6th Bone Marrow Transplant performed in subjects on studyPopulation: Data was not collected for this outcome measure
Determine the level of toxicity experienced by subjects who receive protocol treatment and bone marrow transplant
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-transplant procedure through deathPopulation: Data was not collected for this outcome measure
Review and assess the tumor response rate
Outcome measures
Outcome data not reported
Adverse Events
Study Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place