Hematologic Diseases
Conditions
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
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | 90 days after (CAR)-T cell therapy initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival rate | 1 year | — |
| Objective response rate | 30 days | — |
| Progression-free survival | at 1 year | — |
| Proportion of patients with a cytokine release syndrome | at baseline | Cytokine release syndrome will be assessed by CTCAE v5.0 |
| Proportion of patients with an admission in intensive care | at 30 days | — |
| Severity of neurological toxicities | at 30 days | Severity of neurological toxicities will be assessed by physical, and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Incidence of adverse events | at 30 days | — |
Contacts
Primary ContactCatherine Thieblemont
Backup ContactMatthieu RESCHE-RIGON
Outcome results
None listed