Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consol
The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are: * Will the
| Condition(s) | DLBCL - Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, DLBCL, Nos Genetic Subtypes, High Grade B-Cell Lymphoma, Not Oth |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are: * Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant? * Is consolidation epcoritamab after ASCT deliverable and safe? * Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease? * Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of |
| Who can participate | Inclusion Criteria: 1. Age 18 years or older 2. Confirmed diagnosis of DLBCL, Not-otherwise specified (NOS), Transformation of indolent B-cell lymphoma, High-grade B-cell lymphoma (HGBCL), NOS, Diffuse-large BCL (DLBCL)/ High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements or Follicular large B-cell lymphoma according to World Health Organization (WHO) 2016 or 2022 criteria that has relapsed or progressed after one line of chemoimmunotherapy 3. Transplant eligible according to local assessment 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5cm in longest axis or an extranodal site greater than 1.0cm in longest axis AND baseline fluorodeoxyglucose (FDG) positron |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Australasian Leukaemia and Lymphoma Group |
| Locations | Melbourne, Victoria, Australia |
| Start date | 2023-12-11 |
| NCT ID | NCT06287398 |
| Official listing | https://clinicaltrials.gov/study/NCT06287398 |