drugset / Trial / NCT02999633
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2017-03-08
- Primary completion
- 2017-11-14
- Completion
- 2017-11-14
Outcome
Outcome not reported
Stopped (Enrollment): “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”
Publications
- Brillac 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.
- Wang 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isatuximab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Background | Acetaminophen | Small molecule | — | Oral |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Diphenhydramine | Small molecule | — | Intravenous |
| Background | Ranitidine | Unknown | — | Intravenous |