drugset / Trial / NCT06648889

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

NCT06648889

Phase 2 Recruiting 40 enrolled Goethe University Sanofi · collab
NaSingle-groupOpen-labelTreatment

Summary

The planned trial offers treatment cohorts for patients with full cytologic relapse (R/R ALL - Cohort 1), as well as for patients with molecular failure/relapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.

Timeline

Start
2024-10-22
Primary completion
2028-02
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Isatuximab Monoclonal antibody
Background Bortezomib Small molecule