clinical trial · NCT06648889
Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
Goethe University·phase2·recruiting·n = 40
T-ALLIsatuximabIsatuximab
brief 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.
started
Oct 22, 2024
primary completion
Feb 1, 2028
completion
Aug 1, 2028
last updated
Jun 16, 2026
official title
A Multicenter, Single-arm Phase II Study to Assess the Safety, Tolerability, and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (GMALL-Isatuximab)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol