Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Ris
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 p
| Condition(s) | 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 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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, 1, or 2 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The Lymphoma Academic Research Organisation |
| Locations | Créteil, France; Dijon, France; La Tronche, France; Lille, France; Marseille, France; Montpellier, France (+7 more sites) |
| Start date | 2024-06-14 |
| NCT ID | NCT06271057 |
| Official listing | https://clinicaltrials.gov/study/NCT06271057 |