Phase
Condition
Hematologic Cancer
Lymphocytic Leukemia, Acute
Leukemia
Treatment
Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
Clinical Study ID
Ages < 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 phaseor 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 PlayScore ≥ 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 possiblefungal infections must have had at least 2 weeks of appropriate anti-fungalantibiotics 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 useadequate contraception (diaphragm, birth control pills, injections, intrauterinedevice [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)for the duration of treatment. Sexually active men must agree to use barriercontraceptive 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 donorscreening and testing for relevant communicable disease agents and diseases.
Only Peripheral blood stem cells will be used for stem cell source on this studytherefore donor must be willing to undergo G-CSF mobilization and stem cellapheresis. 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 toundergo mobilization and apheresis
Haploidentical Related Donor:
Haploidentical parent or other related donor: Minimum match level fullhaploidentical (at least 5/10; HLA A, B, C, DRB1, DQB1 alleles), but use ofhaploidentical donors with extra matches (e.g. 6, 7, or 8/10) encouraged.
Exclusion
Exclusion Criteria:
Patients who do not meet disease, organ, or infectious criteria.
No suitable donor
Pregnant or lactating patients are ineligible as many of the medications used inthis protocol could be harmful to unborn children and infants
Receiving concomitant chemotherapy, radiation therapy; immunotherapy or otheranti-cancer therapy for treatment of disease other than is specified in theprotocol. Maintenance or other post-HCT therapy can be considered after discussionwith the study PI.
Participating in a concomitant Phase 1 or 2 study involving treatment of disease
Active malignancy other than eligible disease specified in the protocol. Patientswith prior malignancy can be eligible as long as at least 1 year post treatment forthat malignancy.
Study Design
Connect with a study center
Children's Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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