Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
golcadomide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient who understood and voluntarily signed and dated an informed consent prior toany study-specific assessments/procedures being conducted
Adults patients (≥ 18-year-old at the time of signing the informed consent form; noupper age limit)
Eligible for any commercialized market authorized anti-CD19 CAR T-cells
Performance Status 0 or 1
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
Available biopsy for centralized review
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
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)
Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD)if > 60-year-old or Cockcroft-Gault if <60yo) >45 mL/min,
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))
Patient covered by any social security system (France)
Patient who understands and speaks one of the country official languages, unlesslocal regulation authorizes independent translators
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:
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
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
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
Significant pulmonary function impairment and oxygen saturation (SaO2) < 92% on roomair
Significant cardiovascular disease such as New York Heart Association Class III orIV or Objective Class C or D cardiac disease (see appendix 07)
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,or other clinically significant cardiac disease within 6 months of enrollment
History of severe immediate hypersensitivity reaction to any of the agents used inthis study
Current treatment with strong CYP3A4/5 modulators (see appendix 13)
Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential
Any significant medical conditions, laboratory abnormality or psychiatric illnesslikely to interfere with participation in this clinical study (according to theinvestigator's decision)
Person deprived of his/her liberty by a judicial or administrative decision
Person hospitalized without consent
Adult person under legal protection
Study Design
Connect with a study center
Hopital Henri Mondor
Créteil, 94010
FranceActive - Recruiting
Chu Dijon Bourgogne
Dijon, 21000
FranceActive - Recruiting
Chu de Grenoble
La Tronche, 38700
FranceActive - Recruiting
Chru de Lille
Lille, 59037
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13273
FranceActive - Recruiting
Chu de Montpellier
Montpellier, 34090
FranceActive - Recruiting
Chu de Nantes
Nantes, 44093
FranceActive - Recruiting
Hopital Saint-Louis
Paris, 75475
FranceActive - Recruiting
Chu de Bordeaux
Pessac, 33604
FranceActive - Recruiting
Chu Pontchaillou
Rennes, 35033
FranceActive - Recruiting
Centre Henri Becquerel
Rouen, 76038
FranceActive - Recruiting
Iuct Oncopole
Toulouse, 31059
FranceActive - Recruiting
Chu Brabois
Vandœuvre-lès-Nancy, 54511
FranceActive - 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.