Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

• Status: Terminated
• Trial end date: 2017-11-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Acetaminophen; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Diphenhydramine; Promethazine; Ranitidine; Ranitidine bismuth citrate

Criteria

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.