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

This study is for children and young adults (up to 25 years old) with certain blood cancers like leukemia or myelodysplasia. It's testing a new way to prepare for a blood stem cell transplant. You would receive a stem cell transplant where the donor cells are specially treated using a device called CliniMACS. This device removes specific immune cells (alpha/beta T cells and B cells) from the donor's blood. The goal is to see how well this method prevents a common transplant complication called graft-versus-host disease (aGVHD) and helps the new cells settle in (engraftment). The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It is a pilot study, and the phase is not specified. It plans to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, including the incidence and extent of aGVHD and engraftment, will be measured at 1 year after the transplant.

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NCT05794880

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

Recruiting
NAAges 0–25InterventionalTreatment
Medical College of Wisconsin
~40 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 1 year
Leukemia
Acute Myeloid Leukemia in Remission
Myelodysplasia
Acute Lymphoblastic Leukemia in Remission
Chronic Myelogenous Leukemia - Chronic Phase
Chronic Myelogenous Leukemia, Accelerated Phase
Chronic Myelogenous Leukemia With Crisis of Blast Cells
Biphenotypic Acute Leukemia
Lymphoblastic Lymphoma
Burkitt Lymphoma
Burkitt Leukemia
Lymphoma After Relapse
Other Malignant Hematologic Diseases in Remission
1 sites across 1 states
Wisconsin1

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Eligibility criteria

Inclusion

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.
  • 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 ATG1 year