Phase II Trial of Isatuximab Treatment for Adults With Relapsed or Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia Evaluating Two Treatment Approaches

What this Trial Is About

This trial focuses on adults with CD38 positive T-cell Acute Lymphoblastic Leukemia T-ALL who have experienced relapse or refractory disease. It aims to develop data to improve first-line therapy for T-ALL by testing two strategies modifying standard induction therapy with Isatuximab for patients with full cytologic relapse Cohort 1, and using Isatuximab as post-induction therapy to eliminate minimal residual disease MRD in patients with molecular failure or relapse Cohort 2. Participants in Cohort 1 receive two cycles of induction therapy combining standard chemotherapy, Bortezomib, and Isatuximab. Maintenance with Isatuximab may continue until stem cell transplantation SCT, disease progression, unacceptable toxicity, or other reasons. Cohort 2 participants receive at least one 4-week cycle of Isatuximab alone until SCT, hematologic relapse, unacceptable toxicity, or withdrawal. The study evaluates safety and effectiveness within these two groups. During the study, participants undergo scheduled visits with assessments including hematologic response, molecular response, adverse events, quality of life, and hospitalization days. Follow-up can extend up to 18 months to monitor remission status, survival probabilities, relapse incidence, and graft-versus-host disease in patients with prior SCT. Laboratory tests and molecular assessments are performed according to standard of care to measure outcomes and guide treatment continuation or changes.

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