Actively Recruiting

Phase Not Applicable
Age: 0Years - 25Years
All Genders
NCT05794880

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

Led by Medical College of Wisconsin · Updated on 2026-05-13

40

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is younger than 25 years old
  • Diagnosed with one of the following diseases in remission or specified status: acute myeloid leukemia (MRD negative), myelodysplasia, acute lymphoblastic leukemia (MRD negative), chronic myelogenous leukemia (chronic phase, accelerated phase, or blast crisis now in second chronic phase), mixed lineage or biphenotypic acute leukemia (MRD negative), lymphoblastic lymphoma (in remission), Burkitt's lymphoma/leukemia (in remission), lymphoma after relapse (in remission), or other malignant hematologic diseases approved by the principal investigator
  • Karnofsky Performance Status of 60% or higher for patients 16 years and older, or Lansky Play Score of 60 or higher for patients under 16 years
  • Organ function evaluated as per study procedures
  • No active untreated infection; fungal infections must be treated for at least 2 weeks and asymptomatic
  • Signed consent from parent/guardian or patient if 18 years or older
  • Negative pregnancy test for patients capable of childbearing
  • Sexually active patients capable of childbearing must agree to use effective contraception during treatment; sexually active men must use barrier contraception during treatment
  • Donor meets National Marrow Donor Program criteria and is willing to undergo G-CSF mobilization and peripheral blood stem cell collection
  • Unrelated donors must be matched at 9/10 or 10/10 HLA alleles; haploidentical related donors must be at least 5/10 HLA allele match
Not Eligible

You will not qualify if you...

  • Patients who do not meet disease, organ function, or infection criteria
  • No suitable donor available
  • Pregnant or breastfeeding patients
  • Receiving other chemotherapy, radiation, immunotherapy, or anti-cancer treatments not specified in the protocol
  • Participating in other Phase 1 or 2 treatment studies for the disease
  • Active malignancy other than the eligible diseases specified; prior malignancies allowed if at least 1 year post-treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

M

Meredith Beversdorf, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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