NCT06287398

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

StatusRecruiting

PhasePhase 2

SponsorAustralasian Leukaemia and Lymphoma Group

Primary completionNov 2026 (estimated)

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Record History

All 2 versions: 2 with changes below.

Notable Jul 19, 2024 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Mar 2024 to Dec 11, 2023
v2
Feb 28, 2024 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Event-free survival (EFS)

Timeframe: 12 months

Secondary (5)

Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT

Overall response rate (ORR)

Complete response rate (CRR)

Overall Survival (OS)

Progression free survival (PFS)

Arms and interventions

Epcoritamab TreatmentExperimental

Single arm study - All patients undergo same treatment with Epcoritamab for salvage and consolidation phases.

Drugs: Epcoritamab

Sites

1 site in 1 country

Australasian Leukemia and Lymphoma GroupMelbourne, Victoria, Australia

About this trial

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.

Trial details

Enrollment: 39 participants (estimated)
Started: Dec 11, 2023
Study completion: Nov 2031 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: FDA-regulated drug
Conditions: Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Follicular, Recurrence, 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 +2 more
Official title: 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
First posted: Mar 1, 2024
Registry updated: Jul 22, 2024
Last verified: Jul 2024

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