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NCT Number: NCT04209829

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

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Key information

Conditions

Hematologic Diseases Hemic and Lymphatic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Complete response rate

    Time frame: 90 days after (CAR)-T cell therapy initiation

Secondary outcomes

  1. Overall Survival rate

    Time frame: 1 year

  2. Objective response rate

    Time frame: 30 days

  3. Objective response rate

    Time frame: 90 days

  4. Objective response rate

    Time frame: 1 year

  5. Objective response rate

    Time frame: 2 years

  6. Objective response rate

    Time frame: 5 years

  7. Objective response rate

    Time frame: 10 years

  8. Progression-free survival

    Time frame: at 1 year

  9. Incidence of adverse events

    Time frame: at 30 days

  10. Incidence of adverse events

    Time frame: at 90 days

  11. Incidence of adverse events

    Time frame: at 1 year

  12. Incidence of adverse events

    Time frame: at 2 years

  13. Incidence of adverse events

    Time frame: at 5 years

  14. Incidence of adverse events

    Time frame: at 10 years

  15. Proportion of patients with an admission in intensive care

    Time frame: at 30 days

  16. Proportion of patients with an admission in intensive care

    Time frame: at 90 days

  17. Severity of neurological toxicities

    Time frame: at 30 days

    Severity of neurological toxicities will be assessed by physical, and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  18. Severity of neurological toxicities

    Time frame: at 90 days

    Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  19. Severity of neurological toxicities

    Time frame: at 6 months

    Severity of neurological toxicities will be assessed by physical, cognitive examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  20. Severity of neurological toxicities

    Time frame: at 2 years

    Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  21. Severity of neurological toxicities

    Time frame: at 5 years

    Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  22. Severity of neurological toxicities

    Time frame: at 10 years

    Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  23. Proportion of patients with a cytokine release syndrome

    Time frame: at baseline

    Cytokine release syndrome will be assessed by CTCAE v5.0

  24. Proportion of patients with a cytokine release syndrome

    Time frame: at 7 days

    Cytokine release syndrome will be assessed by CTCAE v5.0

  25. Proportion of patients with a cytokine release syndrome

    Time frame: at 30 days

    Cytokine release syndrome will be assessed by CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Thieblemont

CONTACT

[email protected]

+331 42 49 92 36

Matthieu RESCHE-RIGON

CONTACT

[email protected]

0142499742 ext. 0142499742

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: BIOCART-HM

Important dates

Study start
2019
Primary completion
2025
Study completion
2035
First posted
Dec 24, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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