T cell receptor depletion for blood cancer treatment
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
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 |
| Enrollment | 70 (estimated) |
| Ages | N/A to 60 Years |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05735717 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 60 years or younger with histologically confirmed acute leukemias or related hematological malignancies.
Not a fit: Patients who are pregnant, have active infections, or have previously undergone stem cell transplantation may not benefit from this study.
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 performed: Other studies have shown promise with similar T cell depletion strategies, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Minneapolis, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.