Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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 with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
- 6. Signed consent by parent/guardian or able to give consent if ≥18 years.
- 7. Negative pregnancy test for patients capable of childbearing potential
- 8. 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.
- 1. Unrelated donor meets National Marrow Donor Program criteria for donation
- 2. Infectious disease testing
- 3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.
- 4. 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.
- 5. Unrelated Donor:
- 6. Haploidentical Related Donor:
- 1. 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.
- 1. Patients who do not meet disease, organ, or infectious criteria.
- 2. No suitable donor
- 3. Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
- 4. 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.
- 5. Participating in a concomitant Phase 1 or 2 study involving treatment of disease
- 6. 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.
Ages Eligible for Study
0 Years to 25 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No