RecruitingPhase 2NCT06414148

MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma

A Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma (EpLCART)


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

40 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests additional consolidation therapy for patients with large B-cell lymphoma (a type of blood cancer) who had a partial or complete response to CAR T-cell therapy but still have detectable residual cancer in their blood (MRD-positive). Researchers are testing whether adding epcoritamab (a bispecific antibody) with or without lenalidomide and rituximab can eliminate this remaining cancer. **You may be eligible if...** - You are 16 or older with relapsed/refractory large B-cell lymphoma - You received approved CAR T-cell therapy as your most recent treatment - Your cancer showed a partial or complete response on a PET/CT scan after CAR T-cell therapy - You still have detectable cancer cells in your bloodstream (MRD-positive) on a specialized blood test - Your general health is reasonably good (ECOG 0–2) **You may NOT be eligible if...** - Your cancer did not respond to CAR T-cell therapy - You are MRD-negative (no detectable cancer in the blood) - You are under 16 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEpcoritamab

Epcoritamab will be administered as a 28-day cycle. In Cycle 1 and 2, epcoritamab will be given with step up dosing in Cycle 1. From Cycle 3 onwards dosing will be on Day 1 and 15 of each cycle.

DRUGEpcoritamab, lenalidomide and rituximab

Treatment with epcoritamab will be administered following the same dosing schedule as Arm A. On days where rituximab and/or lenalidomide are also due, epcoritamab should be administered last. Patients will receive lenalidomide once daily on Day 1-21 of each 28-day cycle, starting at Cycle 1 through to Cycle 6. Patients will receive rituximab administered by intravenous (IV) infusion on Day 1, 8, 15 and 22 of Cycle 1 and on Day 1 only of Cycles 2-6.


Locations(6)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06414148


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