NCT06287398

Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL

A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Australasian Leukaemia and Lymphoma Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population. Participants will undergo three phases in this trial: 1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab 2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures. 3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.

Conditions

• 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 Otherwise Specified
• Follicular Large Cell Lymphoma, Relapsed
• Follicular Large Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Epcoritamab	Epcoritamab (Epcor) is a bispecific antibody recognizing the T-cell antigen CD3 and the B-cell antigen CD20. Epcor is a supplied as a concentrate for solution for intended subcutaneous injection. The dose must be prepared by a qualified pharmacist using aseptic technique. Epcoritamab-Salvage treatment phase: 2-3 cycles of R-DHAOx therapy (rituximab, dexamethasone, cytarabine, oxaliplatin), given every 21 days combined with Epcoritamab subcutaneous weekly dosing (priming 0.16mg Cycle 1 Day 1, intermediate 0.8mg cycle 1 day 8, full dose 48mg from cycle 1 day 15 onwards) Epcoritamab Consolidation phase: 6 cycles (28 days each) of subcutaneous Epcoritamab, commencing between 6-12 weeks post ASCT. Epcoritamab dosing and timing for consolidation: * Cycle 1 Day 1: Priming (0.16mg) dose * Cycle 1 Day 8: intermediate (0.8mg) dose * Cycle 1 Day 15: full dose 48mg * Cycle 1 Day 22, Cycle 2-3 Days 1, 8, 15 and 22: 48mg * Cycles 4 to 6 - Days 1 and 15 (fortnightly dosing): 48mg

Timeline

• Start date: 2023-12-11
• Primary completion: 2026-11-01
• Completion: 2031-11-01
• First posted: 2024-03-01
• Last updated: 2024-07-22

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study