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

Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Diseases

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Matthieu RESCHE-RIGON; Phone Number: 0142499742 0142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr
• Study Contact Backup: Name: Catherine Thieblemont; Phone Number: +331 42 49 92 36; Email: catherine.thieblemont@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hematological malignancy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with haematological malignancy; Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete response rate	90 days after (CAR)-T cell therapy initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate		2 years
Progression-free survival		at 1 year
Objective response rate		1 year
Overall Survival rate		1 year
Objective response rate		30 days
Objective response rate		90 days
Objective response rate		5 years
Objective response rate		10 years
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2035

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Neoplasms; Hematologic Diseases
• Other Study ID Numbers: APHP190678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No