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NCT Number: NCT05794880

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

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

Recruiting

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Key information

Age range

0 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Amy Moskop

PRINCIPAL_INVESTIGATOR

Meredith Beversdorf, RN

CONTACT

[email protected]

414-266-5891

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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:

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 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.

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 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
  • 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.

Treatment and study plan

Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

Device

Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.

Primary outcomes

  1. Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG

    Time frame: 1 year

Secondary outcomes

  1. Evaluate incidence of chronic GVHD

    Time frame: 5 years

  2. Evaluate time to platelet engraftment

    Time frame: 1 years

  3. Assess incidence of viral infections

    Time frame: 2 years

  4. Evaluate incidence of relapse/progressive disease

    Time frame: 2 years

  5. Evaluate incidence of treatment-related mortality (TRM).

    Time frame: 2 years

  6. Evaluate overall and relapse free survival (RFS) at 1 year

    Time frame: 1 years

Other outcomes

  1. Assess tempo of CD4+ T cell reconstitution.

    Time frame: 2 years

  2. Assess tempo of immune reconstitution.

    Time frame: 2 years

  3. Assess ATG exposure using pre- and post- HCT AUC estimates using ATG dosing module

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Meredith Beversdorf, RN

CONTACT

[email protected]

414-266-5891

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2032
First posted
Apr 3, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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