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Recruiting NCT05794880

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

Trial Parameters

Condition Leukemia
Sponsor Medical College of Wisconsin
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 0 Years
Max Age 25 Years
Start Date 2023-05-01
Completion 2027-05
Interventions
Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

Brief 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 Criteria

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 - Disease status: in remission * Lymphoma after relapse - Disease status: in remission * Other malignant hematologic diseases in remission (to be approved by PI) 3. Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1) 4. Evaluation of organ status as per MCW BMT SOP 5. Infectious disease criteria: No active untreated infection. Patients

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