Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hematologic Diseases
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 600
- Primary Endpoint
- Complete response rate
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Complete response rate
Time Frame: 90 days after (CAR)-T cell therapy initiation
Secondary Outcomes
- 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)
- Proportion of patients with a cytokine release syndrome(at 30 days)