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

Korábbi kezelés

• Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
• Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.
• Participating in a concomitant Phase 1 or 2 study involving treatment of disease

Más betegség

• Patients who do not meet disease, organ, or infectious criteria.
• Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.

Egyéb

• No suitable donor

• 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:
  • 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.