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
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.
Indication: Acute Lymphoblastic Leukemia
Modality: medical device
Target: CliniMACS® (T cell depletion)
Sponsor: Wake Forest University Health Sciences
Source URL: ClinicalTrials.gov
Source updated: Apr 22, 2022
Ingested: Jun 19, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: CliniMACS® (T cell depletion)
View original source fields
Condition raw: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Lymphomas, Bone Marrow Failure, Hemoglobinopathy, Immune Deficiency, Osteopetrosis
Condition normalized: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome, Lymphomas, Bone Marrow Failure, Hemoglobinopathy, Immune Deficiency, Osteopetrosis
Modality raw: medical device
Modality normalized: medical device
Target raw: CliniMACS® (T cell depletion)
Target normalized: CliniMACS® (T cell depletion)