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

Sponsor
Australasian Leukaemia and Lymphoma Group
Study ID
NCT06287398
Phase
PHASE2
Status
Recruiting
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Conditions

  • DLBCL - Diffuse Large B Cell Lymphoma
  • DLBCL, Nos Genetic Subtypes
  • Follicular Large Cell Lymphoma
  • Follicular Large Cell Lymphoma, Relapsed
  • High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • High-grade B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    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

Study Details

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.

Key Dates

Start date
Dec 11, 2023
Status verified
Jul 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2031

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: 12 months ]

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