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
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
• Patient age \< 25 years. Both genders and all races eligible.
• 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)
• Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
• Evaluation of organ status as per MCW BMT SOP
• Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
• Signed consent by parent/guardian or able to give consent if ≥18 years.
• Negative pregnancy test for patients capable of childbearing potential
• Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.
• Donor Eligibility:
• Unrelated donor meets National Marrow Donor Program criteria for donation
• Infectious disease testing
• MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.
• Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.
• Unrelated Donor:
• a. HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis
• Haploidentical Related Donor:
∙ Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5/10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8/10) encouraged.