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

Study Overview
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Brief Summary
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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

Official Title
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Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics

Conditions
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Hematologic Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haematological malignancy<br>Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | 90 days after (CAR)-T cell therapy initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival rate |  | 1 year | 
| Objective response rate |  | 30 days | 
| Objective response rate |  | 90 days | 
| Objective response rate |  | 1 year | 
| Objective response rate |  | 2 years | 
| Objective response rate |  | 5 years | 
| Objective response rate |  | 10 years | 
| Progression-free survival |  | at 1 year | 
| Incidence of adverse events |  | at 30 days | 
| Incidence of adverse events |  | at 90 days | 
| Incidence of adverse events |  | at 1 year | 
| Incidence of adverse events |  | at 2 years | 
| Incidence of adverse events |  | at 5 years | 
| Incidence of adverse events |  | at 10 years | 
| Proportion of patients with an admission in intensive care |  | at 30 days | 
| Proportion of patients with an admission in intensive care |  | at 90 days | 
| Severity of neurological toxicities | Severity of neurological toxicities will be assessed by physical, and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 30 days | 
| Severity of neurological toxicities | Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 90 days | 
| Severity of neurological toxicities | Severity of neurological toxicities will be assessed by physical, cognitive examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 6 months | 
| Severity of neurological toxicities | Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 2 years | 
| Severity of neurological toxicities | Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 5 years | 
| Severity of neurological toxicities | Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | at 10 years | 
| Proportion of patients with a cytokine release syndrome | Cytokine release syndrome will be assessed by CTCAE v5.0 | at baseline | 
| Proportion of patients with a cytokine release syndrome | Cytokine release syndrome will be assessed by CTCAE v5.0 | at 7 days | 
| Proportion of patients with a cytokine release syndrome | Cytokine release syndrome will be assessed by CTCAE v5.0 | at 30 days |