Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics

Not yet recruiting

• Conditions: Hematologic Diseases

• Registration Number: NCT04209829
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its microenvironment.

The objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to CAR-T Cells therapy in patients with hematologic malignancies

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-11-22
• Study Start: 2019-12
• Study First Submitted QC: 2019-12-20
• Last Update Submitted: 2019-12-20
• Study First Posted: 2019-12-24
• Last Update Posted: 2019-12-24
• Primary Completion: 2025-03
• Study Completion: 2035-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• patient with hematological malignancy (lymphoma, ALL, MM)
• patient integrated into a CAR-T Cells program treatment
• patient aged 15 years or over
• patient having signed a written consent; as well as his legal representative if <18 years old

Exclusion Criteria

• patient with other hematological malignancies than lymphoma, LAL or MM
• patient's weight <58 kg
• patient treated with another treatment than CAR-T Cells
• patient under tutorship or curatorship
• patient not covered by a health system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response rate	90 days after (CAR)-T cell therapy initiation

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	at 1 year
Overall Survival rate	1 year
Objective response rate	10 years
Incidence of adverse events	at 10 years
Proportion of patients with an admission in intensive care	at 90 days
Severity of neurological toxicities	at 10 years	Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Proportion of patients with a cytokine release syndrome	at 30 days	Cytokine release syndrome will be assessed by CTCAE v5.0