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Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

NCT02999633 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-03-21

Study results available
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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.

Conditions

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

Interventions

DRUG

Isatuximab SAR650984

Pharmaceutical form:solution Route of administration: intravenous

DRUG

dexamethasone

Pharmaceutical form:pills Route of administration: oral

DRUG

dexamethasone

Pharmaceutical form:solution Route of administration: intravenous

DRUG

acetaminophen

Pharmaceutical form:pills Route of administration: oral

DRUG

ranitidine

Pharmaceutical form:solution Route of administration: intravenous

DRUG

diphenhydramine

Pharmaceutical form:solution Route of administration: intravenous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2017-11-14
Completion
2017-11-14
FDA Drug
Yes

Countries

  • United States
  • Finland
  • France
  • Hungary
  • Italy
  • Lithuania
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02999633 on ClinicalTrials.gov