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

NCT04640909 | Unknown

• 1 other identifier: CLL2020
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

CLL; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Cell killing rate of anti-CD19 CAR T cells

  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).

  After 12 months of treatment

Study Arms (1)

CAR T Cells generation

OTHER

CAR T Cells generation at baseline and after 6 and 12 months of treatment

Other: Peripheral blood samples withdrawal

Interventions

Peripheral blood samples withdrawal OTHER

Peripheral blood samples evaluation

CAR T Cells generation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (2)

Irccs Ospedale S. Raffaele - Milano - Unità Neoplasie Linfocitarie B

Milan, Italy

RECRUITING

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paola Fazi

CONTACT

0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514; e.crea@gimema.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 23, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 4, 2022

Record last verified: 2021-10

Locations

IT (2)