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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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