Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia (ISLAY)

Sanofi

Status and phase: Terminated; Phase 2

Conditions: T-cell Type Acute Leukemia-Precursor; T-lymphoblastic Lymphoma/Leukaemia

Treatments: Drug: dexamethasone; Drug: acetaminophen; Drug: ranitidine; Drug: Isatuximab SAR650984; Drug: diphenhydramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02999633

ACT14596

2016-002739-14 (EudraCT Number)

U1111-1179-5294 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.

Enrollment: 14 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Isatuximab

Experimental group

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).

Treatment:

Drug: dexamethasone

Drug: Isatuximab SAR650984

Drug: acetaminophen

Drug: diphenhydramine

Drug: ranitidine

Drug: dexamethasone