A Multicenter, Single-arm Phase II Study to Assess Isatuximab in Adults With Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating Isatuximab in adults with relapsed or refractory CD38 positive T-cell Acute Lymphoblastic Leukemia (T-ALL). The study includes two patient groups: those with full cytologic relapse (Cohort 1) and those with molecular failure or relapse but hematologic remission (Cohort 2). The trial aims to optimize initial therapy by modifying induction treatment or establishing post-induction therapy to eliminate minimal residual disease (MRD). Participants in Cohort 1 will receive two cycles of induction therapy combining standard chemotherapy, Bortezomib, and Isatuximab, with possible Isatuximab maintenance until stem cell transplant, disease progression, or other endpoints. Cohort 2 patients will receive Isatuximab alone in cycles of four weeks, continuing until stem cell transplant, relapse, or other specified reasons. The study evaluates these two strategies simultaneously. Participants will undergo assessments including hematologic response, molecular response, adverse event monitoring, and quality of life measurements at various time points such as Day 22, Week 9, and months 3 and 6. Secondary outcomes include remission probabilities, survival rates, relapse incidence, graft-versus-host disease monitoring, treatment adherence, and hospitalization days. The overall participation period averages 18 months with ongoing safety and efficacy evaluations.

Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia