Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2017-11-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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T-cell Type Acute Leukemia-Precursor T-lymphoblastic Lymphoma/Leukaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isatuximab

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).

Group Type EXPERIMENTAL