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Impact of Treatment With Targeted Therapies on the Generation of CAR T Cells in CLL Patients

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ClinicalTrials.gov Identifier: NCT04640909
Recruitment Status : Not yet recruiting
First Posted : November 23, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
In this biological study, blood samples will be collected from patients with CLL treated with targeted agents (ibrutinib and venetoclax) to assess the impact of these treatments on the generation of CAR T cells in terms of manufacturing efficiency, immunophenotypic characteristics and functional properties.

Condition or disease Intervention/treatment Phase
CLL Chronic Lymphocytic Leukemia Other: Peripheral blood samples withdrawal Not Applicable

Detailed Description:

This is a biological study aimed at analyzing the features of CAR T cells generated in CLL patients treated with ibrutinib or venetoclax.

To this purpose, blood samples will be collected from patients with CLL before starting therapy with ibrutinib or venetoclax and after 6 and 12 months of treatment.

Anti-CD19 CAR T cells will be generated and tested for: (i) viability, expansion and generation efficiency; (ii) phenotypic characteristics, in terms of CD4/CD8 composition, differentiation subset distribution, exhaustion markers and expression of immune checkpoint molecules; (iii) in vitro functional properties, in terms of proliferation ability, cytokines production, cytotoxic activity and killing of target cells. CAR T cells produced from the same patient at different timepoints will be compared. Phenotypic and functional data on CAR T cells will be also correlated with main CLL prognostic factors (e.g. IGHV mutational status, FISH abnormalities, TP53 mutation status) and outcome variables (response status, duration of response).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Treatment With Targeted Therapies on the Generation of Effective CAR T Cells in Patients With Chronic Lymphocytic Leukemia
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
CAR T Cells generation
CAR T Cells generation at baseline and after 6 and 12 months of treatment
Other: Peripheral blood samples withdrawal
Peripheral blood samples evaluation




Primary Outcome Measures :
  1. Cell killing rate of anti-CD19 CAR T cells [ Time Frame: After 12 months of treatment ]
    Assessment of the cytotoxic functions of anti-CD19 CAR T cells generated from CLL patients in terms of cell killing rate before and during treatment with targeted agents (i.e. ibrutinib or venetoclax).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CLL/SLL meeting the IWCLL 2008 criteria;
  • ≥18 years old;
  • Indication for treatment with targeted therapies (i.e. ibrutinib or venetoclax);
  • Anticipated possibility to collect blood samples at the baseline and at 6- and 12-month timepoints;
  • Signed written informed consent according to ICH/EU/GCP and national local laws;
  • Confirmed availability of the laboratory to enroll and to process patient samples.

Exclusion Criteria:

  • Expected treatment duration with targeted drug < 12 months, according to treating physician;
  • Previously treated with more than 2 lines of CLL-directed therapy;
  • Concurrent use of systemic steroids or chronic use of immunosuppressive medications;
  • Active HBV (HBsAg+ or HBV DNA+) or HCV or HIV infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640909


Contacts
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04640909    
Other Study ID Numbers: CLL2020
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell