A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|