Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-10-17; most recent amendment 2026-06-18.
Status change: Not Yet Recruiting → Recruiting 2024-12-03
Trial Details
NCT Number NCT06648889
Lead Sponsor Goethe University
Collaborators: Sanofi
Conditions T-ALL
Enrollment 40 participants
Start Date 2024-10-22
Primary Completion 2028-02 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-23