A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative
|ClinicalTrials.gov Identifier: NCT00429143|
Recruitment Status : Completed
First Posted : January 31, 2007
Results First Posted : May 31, 2013
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Radiation: Total Body Irradiation (TBI) Biological: Donor Lymphocyte Infusion (DLI) Drug: Cyclophosphamide (CY) Drug: Tacrolimus Drug: Mycophenolate Mofetil (MMF) Biological: Hematopoietic Stem Cell Transplant (HSCT)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Step Approach To Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies From HLA Partially-Matched Related Donors|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||June 2010|
Experimental: Haploidentical Allogeneic Transplantation
Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
Radiation: Total Body Irradiation (TBI)
TBI twice daily days 6-9 prior to transplant (HSCT)
Biological: Donor Lymphocyte Infusion (DLI)
DLI given 6 days prior to transplant (HSCT).
Drug: Cyclophosphamide (CY)
Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).
Tacrolimus given one day prior to transplant (HSCT).
Drug: Mycophenolate Mofetil (MMF)
MMF given one day prior to transplant (HSCT).
Biological: Hematopoietic Stem Cell Transplant (HSCT)
CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed. This is the day of transplantation.
- Overall Survival of Participants [ Time Frame: 6 months ]To determine overall survival at 6 months post-transplant.
- Optimal Dose of CD3+ Donor Lymphocytes (T-cells) for Consistent Engraftment Without GVHD [ Time Frame: 6 months ]
To determine the optimal dose of CD3+ donor lymphocytes required for consistent engraftment without the development of grade III/IV GVHD.
Measured as CD3+ donor lymphocytes given as n x 10^8/kg.
"n" was found to be 2 and was found to be the optimal dose and was the only dose given.
- Engraftment Rates [ Time Frame: 6 months ]To assess hematopoietic engraftment rates.
- Lymphoid Recovery [ Time Frame: 6 months ]To assess the pace of lymphoid recovery in this patient population.
- Incidence of Grades III-IV GVHD [ Time Frame: 6 months ]
To determine the incidence and severity of GVHD in these patients using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.'
Severity was graded using CTCAE 3.0 (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429143
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Neal Flomenberg, MD||Thomas Jefferson University|