T-cell Depleted Alternative Donor Transplantation
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an alternative (unrelated and mismatched related) donor. The secondary objectives include evaluation of engraftment, immune recovery, and post-transplant infections.
Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant disease will be included in the study. The recipients will be grouped into one of two groups based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The patient will receive a conditioning regimen including chemotherapy drugs and/or total body irradiation based on the disease for which the transplant is performed.
|Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Chronic Myeloid Leukemia Myelodysplastic Syndrome Lymphomas Bone Marrow Failure Hemoglobinopathy Immune Deficiency Osteopetrosis||Device: CliniMACS® (T cell depletion)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients|
- Determine rate of severe GVHD. [ Time Frame: Within 30 days after stem cell transplant ]
- Evaluate the rate of engraftment [ Time Frame: Within 28 days after stem cell transplant ]
- Evaluate post-transplant infections [ Time Frame: 5 years ]
- Evaluate rate of EBV-related post transplant lymphoproliferative disorder (PTLD) [ Time Frame: 5 years ]
- Evaluate post-transplant leukemia relapse [ Time Frame: 5 years ]
- Evaluate transplant-related mortality [ Time Frame: 5 years ]
- Evaluate transplant-related toxicities [ Time Frame: 5 years ]
- Evaluate overall survival [ Time Frame: 5 years ]
- Monitor device performance: purity of selected product, yield of CD34+ cells, CD3+ cell depletion, viability and sterility. [ Time Frame: Length of the trial (5 years) ]
|Study Start Date:||August 2009|
|Study Completion Date:||November 2016|
|Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: T cell depletion using CliniMACS®
Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.
Device: CliniMACS® (T cell depletion)
Stem cells will be collected from donors after they receive Granulocyte colony-stimulating factor (G-CSF). The cells will be processed using the CliniMACS device to select for CD34+ stem cells and to deplete T cells. Recipients will receive conditioning therapy that is based on their disease type and then receive the CD34+ stem cells.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968864
|United States, North Carolina|
|Levine Children's Hospital, Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||Andrew Gilman, MD||Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System|