Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics
BIOCART-HM
1 other identifier
observational
600
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2035
ExpectedDecember 24, 2019
October 1, 2019
5.3 years
November 22, 2019
December 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response rate
90 days after (CAR)-T cell therapy initiation
Secondary Outcomes (25)
Overall Survival rate
1 year
Objective response rate
30 days
Objective response rate
90 days
Objective response rate
1 year
Objective response rate
2 years
- +20 more secondary outcomes
Study Arms (1)
Patients with haematological malignancy
Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment
Eligibility Criteria
Patients with hematological malignancy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2019
First Posted
December 24, 2019
Study Start
December 1, 2019
Primary Completion
March 1, 2025
Study Completion (Estimated)
March 1, 2035
Last Updated
December 24, 2019
Record last verified: 2019-10