Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hematologic Diseases. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Primary outcome measures
- Complete response rate [Time frame: 90 days after (CAR)-T cell therapy initiation]
Secondary outcome measures (12)
- Overall Survival rate [Time frame: 1 year]
- Objective response rate [Time frame: 30 days]
- Objective response rate [Time frame: 90 days]
- Objective response rate [Time frame: 1 year]
- Objective response rate [Time frame: 2 years]
- Objective response rate [Time frame: 5 years]
- Objective response rate [Time frame: 10 years]
- Progression-free survival [Time frame: at 1 year]
- Incidence of adverse events [Time frame: at 30 days]
- Incidence of adverse events [Time frame: at 90 days]
- Incidence of adverse events [Time frame: at 1 year]
- Incidence of adverse events [Time frame: at 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04209829 · APHP190678