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

NCT06287398 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-07-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Australasian Leukaemia and Lymphoma Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2026-11-30
Completion
2031-11-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287398 on ClinicalTrials.gov