Golcadomide treatment after CAR T-cell therapy for aggressive large B-cell lymphoma
Golcadomide (BMS-986369) Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
PHASE2 · The Lymphoma Academic Research Organisation · NCT06271057
This study is testing if golcadomide can help people with aggressive large B-cell lymphoma stay in remission after they receive CAR T-cell therapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Lymphoma Academic Research Organisation (other) |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 13 sites (Créteil and 12 other locations) |
| Trial ID | NCT06271057 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial is an open-label, multicenter study aimed at evaluating the efficacy of golcadomide in patients with aggressive large B-cell lymphoma who are at high risk of relapse after receiving CAR T-cell therapy. Approximately 65 patients will be enrolled, and treatment will last for 24 weeks, consisting of 6 cycles of 28 days each, starting 5 days post-CAR T-cell infusion. The primary objective is to assess the complete metabolic response rate at 3 months following the infusion of CAR T-cells. Safety analyses will be conducted, with enrollment paused after the first 3 patients complete treatment or discontinue.
Who should consider this trial
Good fit: Ideal candidates are adults with aggressive large B-cell lymphoma who are eligible for CAR T-cell therapy and have a performance status of 0 or 1.
Not a fit: Patients with primary CNS lymphoma or those who do not meet the eligibility criteria for CAR T-cell therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with aggressive large B-cell lymphoma who are at high risk of relapse after CAR T-cell therapy.
How similar studies have performed: While this approach is novel in the context of golcadomide post-CAR T-cell therapy, similar studies have shown promise in utilizing CAR T-cell therapy for aggressive lymphomas.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper 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
6. Available biopsy for centralized review
7. With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment
8. Total MetabolicTumor Volume (TMTV) \> 80 ml, measured by centralized review, on 18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +/- 4 days before CAR-T cells infusion)
9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \> 60-year-old or Cockcroft-Gault if \<60yo) \>45 mL/min,
10. 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's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg/dL (51 μmol/L))
11. Patient covered by any social security system (France)
12. Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators
13. Contraception:
* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year, as soon as consent is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, Women must refrain from donating eggs during this same period.
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 is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor
3. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines
4. Significant pulmonary function impairment and oxygen saturation (SaO2) \< 92% on room air
5. Significant cardiovascular disease such as New York Heart Association Class III or IV 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 in this 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 illness likely to interfere with participation in this clinical study (according to the investigator'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
Where this trial is running
Créteil and 12 other locations
- Hopital Henri Mondor — Créteil, France (RECRUITING)
- Chu Dijon Bourgogne — Dijon, France (RECRUITING)
- Chu de Grenoble — La Tronche, France (RECRUITING)
- Chru de Lille — Lille, France (RECRUITING)
- Institut Paoli Calmettes — Marseille, France (RECRUITING)
- Chu de Montpellier — Montpellier, France (RECRUITING)
- Chu de Nantes — Nantes, France (RECRUITING)
- Hopital Saint-Louis — Paris, France (RECRUITING)
- Chu de Bordeaux — Pessac, France (RECRUITING)
- Chu Pontchaillou — Rennes, France (RECRUITING)
- Centre Henri Becquerel — Rouen, France (RECRUITING)
- Iuct Oncopole — Toulouse, France (RECRUITING)
- Chu Brabois — Vandœuvre-lès-Nancy, France (RECRUITING)
Study contacts
- Principal investigator: Catherine THIEBLEMONT, Prof. Dr. — Hôpital Saint-Louis
- Study coordinator: Stéphanie DOYEN
- Email: stephanie.doyen@lysarc.org
- Phone: +33 4 27 01 27 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diffuse Large B-cell Lymphoma Refractory, Refractory Primary Mediastinal Large B-Cell Lymphoma, Refractory Transformed B-cell Non-Hodgkin Lymphoma, Refractory High Grade B-Cell Lymphoma, eligible for CAR T-cells therapy