Under construction – not a live service
Sign in
Taking people in United StatesNo phase

Tests a T-cell and B-cell removal method in blood cancer stem cell transplants

Tests a cell-removal device with targeted ATG dosing in people with blood cancers receiving transplants.

Key facts

Who runs it
Medical College of Wisconsin
Where
Milwaukee, United StatesSee the site
Trial code
Registry title
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing
Status
Recruiting
People taking part
40 people, planned
Started
1 May 2023
Expected to end
May 2032
Type of study
Interventional
Treatments tested
  • Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
Record updated
13 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people under 25 with blood cancers in remission who need a stem cell transplant from an unrelated or a half-matched family donor.

Age
Under 25 years (0 to 25 years).
Sex
Both sexes can join.
Disease stage
Blood cancers in remission or without measurable disease: acute myeloid leukemia, acute lymphoblastic leukemia, biphenotypic leukemia, lymphoblastic lymphoma, Burkitt lymphoma, lymphoma after relapse, myelodysplasia. Chronic myelogenous leukemia in chronic phase, accelerated phase or blast crisis now in second chronic phase.
Earlier treatment
Patients with a past cancer must be at least 1 year past treatment for it. Possible fungal infection needs at least 2 weeks of antifungal treatment and no symptoms.
Biomarker or test result
The donor needs high resolution HLA typing. An unrelated donor must be matched at 9/10 or 10/10 alleles. A haploidentical related donor must share at least 5/10 alleles.

Main reasons for not taking part

  • Pregnant or breastfeeding
  • No suitable donor available
  • Active infection that is untreated
  • Other cancer treatment at the same time, outside the protocol
  • Taking part in another phase 1 or 2 treatment study

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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:; 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

Who cannot take part

  • 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
  • Patients who do not meet disease, organ, or infectious criteria
  • 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
  • No suitable donor

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 25 years old?

Where in United States

  • Children's WisconsinMilwaukee, United StatesContact: Meredith Beversdorf, RNTaking people

About the trial

What the trial wants to find out

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

The group in the trial

  • Alpha/Beta T cell depletion (TCD) plus CD19+ depletionTreatment being tested

    Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies

    Treatment: Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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
Plain-language title
Tests a T-cell and B-cell removal method in blood cancer stem cell transplantsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05794880, who can take part
Record updated
13 May 2026