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

ConditionsDLBCL - Diffuse Large B Cell LymphomaHigh-grade B-cell LymphomaHigh Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsDLBCL, Nos Genetic SubtypesHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedFollicular Large Cell Lymphoma, RelapsedFollicular Large Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustralasian Leukaemia and Lymphoma Group

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

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

Transplant eligible according to local assessment

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Disqualifiers

Diagnosis of primary Central Nervous System (CNS) lymphoma

Active secondary CNS involvement of lymphoma at time of screening

Prior autologous stem cell transplant

Cervical carcinoma of Stage 1B or less.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Epcoritamab TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Event-free survival (EFS)

Time to event outcome measured in days from commencement of each treatment subset (salvage chemotherapy and Epcoritamab/ASCT/ Epcoritamab re-treatment) to date of first to occur out of reduced partial response (PR) after C2, commencement of non-protocolised cancer treatment, progression or death from any cause.

Time frame
12 months

Secondary outcomes

1

Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT

Rate of adverse events according to CTCAE criteria v 6.0 expressed as a number and proportion.

Time frame
From enrolment to 30 days after the final treatment is completed.
2

Overall response rate (ORR)

Defined as achievement of at least a partial response to treatment according to Lugano criteria i.e. achievement of a PR or CR at any time during study participation

Time frame
At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).
3

Complete response rate (CRR)

Defined as achievement of CR at any time during study according to Lugano criteria

Time frame
At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).
4

Overall Survival (OS)

Defined as the time from commencement of study treatment until death from any cause

Time frame
At cycle 2 day 21 (each cycle is 28 days), cycle 3 day 21, 4 weeks post ASCT, 12 months from registration and 3-monthly during follow up (up to 24 months from registration).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Australasian Leukaemia and Lymphoma Group

Lead sponsor

Source ClinicalTrials.gov
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