Clinical trial NCT04209829: Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics
Official title: Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hematologic Diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 600
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematological malignancy

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


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

Primary outcomes:
measure: Complete response rate
timeFrame: 90 days after (CAR)-T cell therapy initiation
Secondary outcomes:
measure: Overall Survival rate
timeFrame: 1 year
measure: Objective response rate
timeFrame: 30 days
measure: Objective response rate
timeFrame: 90 days
measure: Objective response rate
timeFrame: 1 year
measure: Objective response rate
timeFrame: 2 years
measure: Objective response rate
timeFrame: 5 years
measure: Objective response rate
timeFrame: 10 years
measure: Progression-free survival
timeFrame: at 1 year
measure: Incidence of adverse events
timeFrame: at 30 days
measure: Incidence of adverse events
timeFrame: at 90 days
measure: Incidence of adverse events
timeFrame: at 1 year
measure: Incidence of adverse events
timeFrame: at 2 years
measure: Incidence of adverse events
timeFrame: at 5 years
measure: Incidence of adverse events
timeFrame: at 10 years
measure: Proportion of patients with an admission in intensive care
timeFrame: at 30 days
measure: Proportion of patients with an admission in intensive care
timeFrame: at 90 days
measure: Severity of neurological toxicities
timeFrame: at 30 days
measure: Severity of neurological toxicities
timeFrame: at 90 days
measure: Severity of neurological toxicities
timeFrame: at 6 months
measure: Severity of neurological toxicities
timeFrame: at 2 years
measure: Severity of neurological toxicities
timeFrame: at 5 years
measure: Severity of neurological toxicities
timeFrame: at 10 years
measure: Proportion of patients with a cytokine release syndrome
timeFrame: at baseline
measure: Proportion of patients with a cytokine release syndrome
timeFrame: at 7 days
measure: Proportion of patients with a cytokine release syndrome
timeFrame: at 30 days
Other outcomes:
Locations:
Study officials:
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