Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Phase 1

• Conditions: Cancer; MedDRA version: 21.1Level: PTClassification code 10036543Term: Precursor T-lymphoblastic lymphoma/leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10042987Term: T-cell type acute leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002739-14-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-14
• Study Start: 2021-05-27
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

-Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy
-Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration
-Patients must have 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified