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
Medical College of Wisconsin
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
Eligibility
- Age range
- 0–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient age \< 25 years. Both genders and all races eligible. 2. Disease eligibility * Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%) * Myelodysplasia * Acute lymphoblastic leukemia - Disease status: MRD negative * Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase * Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative * Lymphoblastic lymphoma - Disease status: in remission * Burkitt's lymphoma/leukemia - Dis…
Interventions
- DeviceMagnetic-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.
Location
- Children's WisconsinMilwaukee, Wisconsin