MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "MT2021-08 T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies," is exploring a new treatment approach for patients with certain blood cancers, such as acute leukemia and other related conditions. The study is looking at a procedure called T cell receptor alpha/beta depletion (α/β TCD) in combination with peripheral blood stem cell (PBSC) transplantation to see how effective it is in treating these diseases. It’s currently open for enrollment and welcomes participants aged 60 years or younger who have a confirmed diagnosis of a hematological malignancy and meet specific health criteria.

To be eligible for this trial, participants must have a type of blood cancer like acute myeloid leukemia or acute lymphoblastic leukemia, and they should be in a stable health condition with good organ function. However, individuals who are pregnant, have uncontrolled infections, or have had a prior stem cell transplant are not eligible to participate. If you choose to join the trial, you can expect close monitoring and care throughout the process, as researchers aim to learn more about the safety and effectiveness of this treatment to potentially improve outcomes for patients with these serious conditions.

Gender

ALL

Eligibility 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