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

Last updated: April 25, 2025
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Cancer

Lymphocytic Leukemia, Acute

Leukemia

Treatment

Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

Clinical Study ID

NCT05794880
IIT-MOSKOP-MABD
  • Ages < 25
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion 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 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)

  1. Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky PlayScore ≥ 60 for patients under 16 years of age (Appendix 1)

  2. Evaluation of organ status as per MCW BMT SOP

  3. 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.

  4. Signed consent by parent/guardian or able to give consent if ≥18 years.

  5. Negative pregnancy test for patients capable of childbearing potential

  6. 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:

  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 donorscreening and testing for relevant communicable disease agents and diseases.

  4. 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.

  5. 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

  6. Haploidentical Related Donor:

  7. 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:

  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 inthis protocol could be harmful to unborn children and infants

  4. 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.

  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. Patientswith prior malignancy can be eligible as long as at least 1 year post treatment forthat malignancy.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 31, 2032

Connect with a study center

  • Children's Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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