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NCT00968864TERMINATEDanonymous

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

Sponsor

Source record

Wake Forest University Health Sciences

Phase

Source record

PHASE2

Modality

AI-normalized

medical device

Target

AI-normalized

CliniMACS® (T cell depletion)

Indication / condition

AI-normalized

Acute Lymphoblastic Leukemia

Intervention

Source record

CliniMACS® (T cell depletion)

Source & freshness

Source record

NCT ID

NCT00968864

Original source

ClinicalTrials.gov

Source last updated

Apr 22, 2022

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT00968864

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

Sponsor

Wake Forest University Health Sciences

Status

TERMINATED

Phase

PHASE2

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)

Interventions

CliniMACS® (T cell depletion)

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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