Study Overview

Study Details

Study overview

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

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

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

Condition
Leukemia
Intervention / Treatment

-

Contacts and Locations

Milwaukee

Children's Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

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

Collaborators and Investigators

Medical College of Wisconsin,

Study Record Dates

2032-05