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

Hematologic Diseases Clinical Trial

— BIOCART-HM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04209829
• Other study ID #: APHP190678
• Status: Not yet recruiting
• Start date: December 2019
• Est. completion date: March 2035

Study information

• Verified date: October 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Catherine Thieblemont
• Phone: +331 42 49 92 36
• Email: catherine.thieblemont[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: March 2035
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		90 days after (CAR)-T cell therapy initiation
Secondary	Overall Survival rate		1 year
Secondary	Objective response rate		30 days
Secondary	Objective response rate		90 days
Secondary	Objective response rate		1 year
Secondary	Objective response rate		2 years
Secondary	Objective response rate		5 years
Secondary	Objective response rate		10 years
Secondary	Progression-free survival		at 1 year
Secondary	Incidence of adverse events		at 30 days
Secondary	Incidence of adverse events		at 90 days
Secondary	Incidence of adverse events		at 1 year
Secondary	Incidence of adverse events		at 2 years
Secondary	Incidence of adverse events		at 5 years
Secondary	Incidence of adverse events		at 10 years
Secondary	Proportion of patients with an admission in intensive care		at 30 days
Secondary	Proportion of patients with an admission in intensive care		at 90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients with a cytokine release syndrome	Cytokine release syndrome will be assessed by CTCAE v5.0	at baseline
Secondary	Proportion of patients with a cytokine release syndrome	Cytokine release syndrome will be assessed by CTCAE v5.0	at 7 days
Secondary	Proportion of patients with a cytokine release syndrome	Cytokine release syndrome will be assessed by CTCAE v5.0	at 30 days