Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haematological malignancy | Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | 90 days after (CAR)-T cell therapy initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival rate | 1 year | |
| Objective response rate | 30 days | |
| Objective response rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with hematological malignancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Thieblemont | Contact | +331 42 49 92 36 | catherine.thieblemont@aphp.fr | |
| Matthieu RESCHE-RIGON | Contact | 0142499742 | 0142499742 | matthieu.resche-rigon@univ-paris-diderot.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |