Actively Recruiting
MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-06-05
40
Participants Needed
6
Research Sites
206 weeks
Total Duration
On this page
Sponsors
P
Peter MacCallum Cancer Centre, Australia
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 16 years or older at consent
- ECOG performance status between 0 and 2
- Diagnosis of relapsed or refractory large B-cell lymphoma
- Received approved anti-CD19 CAR T-cell therapy as most recent treatment
- Partial or complete metabolic response by Lugano criteria on PET/CT between Day 25 and Day 100 post CAR T-cell infusion
- MRD positive by ctDNA assay on blood sample between Day 25 and Day 100 post CAR T-cell infusion
- Adequate blood cell counts within 7 days prior to randomization
- Adequate heart function
- Adequate kidney function within 7 days prior to randomization
- Adequate liver function within 7 days prior to randomization
- Complete recovery from cytokine release syndrome, macrophage activation syndrome, or immune effector cell neurotoxicity related to prior CAR T-cell therapy
- Women of childbearing potential willing to use contraception as described
- Sexually active men agree to use condoms during study and for 4 months after last epcoritamab dose
- Women agree not to donate eggs and men agree not to donate sperm during study and 4 months after last epcoritamab dose
- Patient understands the trial purpose and agrees to comply with protocol requirements
You will not qualify if you...
- History of Grade 4 cytokine release syndrome or neurotoxicity from prior CAR T-cell therapy
- Lymphoma that is CD20 negative on most recent biopsy before CAR T-cell therapy
- Active infection requiring systemic treatment
- Progression or relapse within 3 months after treatment with bispecific antibody targeting CD3 and CD20
- Diagnosis of primary central nervous system lymphoma
- Active secondary CNS lymphoma involvement at screening
- History or current autoimmune disease or permanent immunosuppression
- Known cognitive impairment increasing risk of neurotoxicity
- History of acute or chronic hepatitis B infection
- History of acute or chronic hepatitis C infection
- History of HIV infection
- Comorbidity reducing life expectancy to less than 5 years or impacting ability to complete study
- Received live or live attenuated vaccine within 4 weeks before consent
- Pregnant or breastfeeding women
- Known allergy to epcoritamab, lenalidomide, rituximab, tocilizumab, or their ingredients
- Psychological, social, geographical, or other conditions making participation unsuitable
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
2
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
3
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Not Yet Recruiting
4
Alfred Hospital
Melbourne, Victoria, Australia, 3000
Actively Recruiting
5
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
6
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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