New stem cell transplant method aims to cut complications in young blood cancer patients
NCT ID NCT05794880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests a stem cell transplant method that removes specific immune cells (alpha/beta T cells and B cells) from the donor cells before transplant. The goal is to reduce the risk of graft-versus-host disease, a serious complication, while still allowing the transplant to work. Up to 40 children and young adults with various blood cancers will receive this treatment, and researchers will monitor engraftment, side effects, and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cell transplant with T-cell and B-cell depletion using CliniMACS device
- What this could lead to
- If successful, this approach could reduce severe graft-versus-host disease and improve survival after stem cell transplants for blood cancers.
- What could go wrong
- This is a small, early pilot study with only 40 participants, so results may not apply broadly. Risks include infection, graft failure, or relapse of the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 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. Donor Eligibility: 1. Unrelated donor meets National Marrow Donor Program criteria for donation 2. Infectious disease testing 3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases. 4. 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. 5. Unrelated Donor: a. 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 6. Haploidentical Related Donor: 1. 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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- Ultrasound may reveal hidden bone damage in blood cancers
- Can a pill keep blood cancer at bay after a stem cell transplant?