NCT05794880

MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 0 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival

Conditions

• Leukemia
• Acute Myeloid Leukemia in Remission
• Myelodysplasia
• Acute Lymphoblastic Leukemia in Remission
• Chronic Myelogenous Leukemia - Chronic Phase
• Chronic Myelogenous Leukemia, Accelerated Phase
• Chronic Myelogenous Leukemia With Crisis of Blast Cells
• Biphenotypic Acute Leukemia
• Lymphoblastic Lymphoma
• Burkitt Lymphoma
• Burkitt Leukemia
• Lymphoma After Relapse
• Other Malignant Hematologic Diseases in Remission

Interventions

Type	Name	Description
DEVICE	Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)	Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.

Timeline

• Start date: 2023-05-01
• Primary completion: 2027-05-01
• Completion: 2032-05-01
• First posted: 2023-04-03
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study