T cell receptor depletion for blood cancer treatment
Official title: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies
Run by Masonic Cancer Center, University of Minnesota · NCT05735717 · Data updated 2026-11-12
This study is testing a new way to treat blood cancers by using a special treatment before a stem cell transplant to see if it helps both kids and adults do better after the procedure.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 60 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | May 11, 2023 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2030 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT05735717 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 60 years or younger with histologically confirmed acute leukemias or related hematological malignancies.
✕Probably not a fit
Patients who are pregnant, have active infections, or have previously undergone stem cell transplantation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II, open-label study investigates the use of T cell receptor alpha/beta depletion in peripheral blood stem cell transplantation for patients with hematological malignancies, including acute leukemias. The study aims to evaluate the safety and efficacy of this approach in both children and adults. Participants will receive a preparative regimen that includes Fludarabine, Busulfan, and Melphalan, among other treatments. The goal is to improve outcomes for patients undergoing transplantation for these serious conditions.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of stem cell transplantation for patients with hematological malignancies.
How similar studies have gone: Other studies have shown promise with similar T cell depletion strategies, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological confirmation of hematological malignancies * Acute leukemias * Acute Myeloid Leukemia (AML) and related precursor neoplasms * Favorable risk AML is defined as having one of the following: * Acute lymphoblastic leukemia (ALL)/lymphoma * Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. * Age 60 years of age or younger at the time of consent * Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age. * Adequate organ function Exclusion Criteria: * Pregnant or breastfeeding. * Active uncontrolled infection within 1 week of starting preparative therapy * Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR. * Any prior autologous or allogeneic transplant * CML blast crisis * Active central nervous system malignancy
Where it's running
-
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Margaret MacMillan — Masonic Cancer Center, University of Minnesota
- Study coordinator: Margaret MacMillan
- Email: macmi002@umn.edu
- Phone: 612-626-2961
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.