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MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing | Clinical Trials | Clareo Health

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

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

NCT05794880•Medical College of Wisconsin

View on ClinicalTrials.gov

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

Age

0 - 25 years

Sex

ALL

Healthy Volunteers

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 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
+16 more criteria

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 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.

Locations (1)

Children's Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

May 1, 2023

Primary Completion Date

May 1, 2027

Completion Date

May 1, 2032

Last Updated

April 29, 2025

Enrollment

ESTIMATED participants

Conditions

LeukemiaAcute Myeloid Leukemia in RemissionMyelodysplasiaAcute Lymphoblastic Leukemia in RemissionChronic Myelogenous Leukemia - Chronic PhaseChronic Myelogenous Leukemia, Accelerated PhaseChronic Myelogenous Leukemia With Crisis of Blast CellsBiphenotypic Acute LeukemiaLymphoblastic LymphomaBurkitt LymphomaBurkitt LeukemiaLymphoma After RelapseOther Malignant Hematologic Diseases in Remission

Interventions

Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

DEVICE

Contacts

Meredith Beversdorf, RN

CONTACT

414-266-5891 mbeversdorf@childrenswi.org

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

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RECRUITINGPHASE1

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Acute Myeloid Leukemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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