Clinical trial · Interventional
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to an unsatisfactory benefit/risk ratio, as specified in \& 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely
Summary
Brief summary (as posted)
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: * To evaluate the safety profile of isatuximab. * To evaluate the duration of response (DOR). * To evaluate progression free survival (PFS) and overall survival (OS). * To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. * To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. * To assess minimal residual disease (MRD) and correlate it with clinical outcome.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-cell Type Acute Leukemia-Precursor | — | UNRESOLVED | — |
| T-lymphoblastic Lymphoma/Leukaemia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetaminophen | Drug | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| diphenhydramine | Drug | — | UNRESOLVED |
| Isatuximab SAR650984 | Drug | — | UNRESOLVED |
| ranitidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Isatuximab
- description
- Participants received intravenous administration of isatuximab at a dose of 20 milligrams/kilogram (mg/kg) at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days).
- interventionNames
- Drug: Isatuximab SAR650984
- Drug: dexamethasone
- Drug: acetaminophen
- Drug: ranitidine
- Drug: diphenhydramine
Primary outcomes (1)
- measure
- Percentage of Participants With Objective Response
- timeFrame
- Baseline until disease progression or death (maximum duration: 12.1 weeks)
- description
- Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion criteria : * Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy. * Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration. * Participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue). * No more than 3 prior salvage therapies. Exclusion criteria: * Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration. * Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration. * Clinical evidence of active central nervous system (CNS) leukemia. * T-ALL with testicular involvement alone. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
References
Publications (2)
- DERIVEDBrillac C, Semiond D, Oprea C, Baruchel A, Zwaan CM, Nguyen L. Selection of isatuximab dosing regimen in pediatric patients with leukemia using population pharmacokinetics. Cancer Chemother Pharmacol. 2025 Dec 3;95(1):116. doi: 10.1007/s00280-025-04832-2. PMID 41331127
- DERIVEDWang A, Song Z, Zheng G, Nicolazzi C, Fromm JR, Shehu E, Srinivasan S, Chen X, Zhu C, Blondel MC, Adrian FJ. Evaluation of Preclinical Activity of Isatuximab in Patients with Acute Lymphoblastic Leukemia. Mol Cancer Ther. 2021 Oct;20(10):1916-1925. doi: 10.1158/1535-7163.MCT-21-0058. Epub 2021 Aug 10. PMID 34376579