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

NCT ID: NCT04209829

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-31

Study Completion Date

2035-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with haematological malignancy

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Catherine Thieblemont

Role: CONTACT

Phone: +331 42 49 92 36

Email: [email protected]

Matthieu RESCHE-RIGON

Role: CONTACT

Phone: 0142499742

Email: [email protected]

Other Identifiers

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APHP190678

Identifier Type: -

Identifier Source: org_study_id