Clinical trial Recruiting at 1 site Phase 2 Interventional Ages Any age to 60

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.

More Acute Myeloid Leukemia trials

Quick facts

PhasePhase 2
Study typeInterventional
AgesAny age to 60 Years
SexAll
Enrollment70 (estimated)
SponsorMasonic Cancer Center, University of Minnesota
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedMay 11, 2023
Main results expectedNovember 30, 2027
Study endsNovember 30, 2030
Registry record updatedApril 6, 2026
Trial IDNCT05735717 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.