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

• Status: Not yet recruiting
• Trial end date: 2030-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Busulfan; Fludarabine; Levetiracetam; Melphalan; Rituximab

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