Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

Last updated: October 8, 2024
Sponsor: The Lymphoma Academic Research Organisation
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

golcadomide

Clinical Study ID

NCT06271057
CARMOD
  • Ages > 18
  • All Genders

Study Summary

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.

Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.

The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.

The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient who understood and voluntarily signed and dated an informed consent prior toany study-specific assessments/procedures being conducted

  2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; noupper age limit)

  3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells

  4. Performance Status 0 or 1

  5. With aggressive large B-cell lymphoma, including:

  • diffuse large B-cell lymphoma

  • Primary mediastinal B-cell lymphoma

  • Any transformed follicular or marginal zone lymphoma

  • high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma

  1. Available biopsy for centralized review

  2. With a CAR T-cells indication as soon as 2nd line treatment no later than in 4thline, previously validated by the multidisciplinary tumor board Note: Any treatmentperformed prior to leukapheresis is considered a line of treatment

  3. Total MetabolicTumor Volume (TMTV) > 80 ml, measured by centralized review, on 18FDG-PET (positron emission tomography) done just before starting CAR T-cellsprocedure (i.e., D-13 +/- 4 days before CAR-T cells infusion)

  4. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD)if > 60-year-old or Cockcroft-Gault if <60yo) >45 mL/min,

  5. Adequate hepatic function:

  • aspartate aminotransferase/alanine aminotransferase (ALT/AST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT/AST must be ≤ 5.0 x ULN)

  • Serum total bilirubin ≤ 2.0 mg/dL (34 μmol/L) (Note: In the case of Gilbert'ssyndrome, or documented liver or pancreatic involvement by lymphoma, serumtotal bilirubin must be ≤ 3.0 mg/dL (51 μmol/L))

  1. Patient covered by any social security system (France)

  2. Patient who understands and speaks one of the country official languages, unlesslocal regulation authorizes independent translators

  3. Contraception:

  • For women of childbearing potential: Agreement to remain abstinent (refrainfrom heterosexual intercourse) or use two adequate methods of contraception,including at least one method with a failure rate of <1% per year, as soon asconsent is signed, during the treatment period (including periods of treatmentinterruption), and for at least 28 days after the last dose of golcadomide,Women must refrain from donating eggs during this same period.

Exclusion

Exclusion Criteria:

  1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg,cervix, bladder, breast) unless disease free for at least 3 years

  2. Presence or suspicion of fungal, bacterial, viral, or other infection that isuncontrolled or requiring IV antimicrobials for management; simple urinary tractinfection and uncomplicated bacterial pharyngitis are permitted if responding toactive treatment and after consultation with the sponsor's medical monitor

  3. History of human immunodeficiency virus (HIV) infection or acute or chronic activehepatitis B or C infection; subjects with history of hepatitis infection must havecleared their infection as determined by standard serological and genetic testingper current Infectious Diseases Society of America guidelines or applicable countryguidelines

  4. Significant pulmonary function impairment and oxygen saturation (SaO2) < 92% on roomair

  5. Significant cardiovascular disease such as New York Heart Association Class III orIV or Objective Class C or D cardiac disease (see appendix 07)

  6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,or other clinically significant cardiac disease within 6 months of enrollment

  7. History of severe immediate hypersensitivity reaction to any of the agents used inthis study

  8. Current treatment with strong CYP3A4/5 modulators (see appendix 13)

  9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential

  10. Any significant medical conditions, laboratory abnormality or psychiatric illnesslikely to interfere with participation in this clinical study (according to theinvestigator's decision)

  11. Person deprived of his/her liberty by a judicial or administrative decision

  12. Person hospitalized without consent

  13. Adult person under legal protection

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: golcadomide
Phase: 2
Study Start date:
June 14, 2024
Estimated Completion Date:
October 20, 2027

Connect with a study center

  • Hopital Henri Mondor

    Créteil, 94010
    France

    Active - Recruiting

  • Chu Dijon Bourgogne

    Dijon, 21000
    France

    Active - Recruiting

  • Chu de Grenoble

    La Tronche, 38700
    France

    Active - Recruiting

  • Chru de Lille

    Lille, 59037
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille, 13273
    France

    Active - Recruiting

  • Chu de Montpellier

    Montpellier, 34090
    France

    Active - Recruiting

  • Chu de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Hopital Saint-Louis

    Paris, 75475
    France

    Active - Recruiting

  • Chu de Bordeaux

    Pessac, 33604
    France

    Active - Recruiting

  • Chu Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Active - Recruiting

  • Iuct Oncopole

    Toulouse, 31059
    France

    Active - Recruiting

  • Chu Brabois

    Vandœuvre-lès-Nancy, 54511
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.