Epcoritamab combined with Rituximab and Lenalidomide for treating untreated Follicular Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of epcoritamab when used alongside rituximab and lenalidomide in adults with previously untreated follicular lymphoma. Participants will be divided into five treatment groups, each receiving different combinations of these therapies. The study aims to assess adverse events and changes in disease activity among approximately 1095 participants across 250 global sites. The goal is to determine the potential benefits of this combination therapy for managing follicular lymphoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of follicular lymphoma (FL).
* Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
* Are willing and able to comply with procedures required in the protocol.
* Must have stage, III, IV or II with bulky disease \>= 7cm).
* Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Has one or more target lesions:

  * A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
  * \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\].
* Have laboratory values meeting the criteria in the protocol.

Exclusion Criteria:

* Had major surgery within 4 weeks prior to randomization.
* Have active cytomegalovirus (CMV) disease.

Where it's running

• UCSF Fresno /ID# 264712
  Fresno, California, United States Recruiting
• Scripps Mercy Hospital /ID# 265393
  San Diego, California, United States Recruiting
• Sansum Clinic Research /ID# 261596
  Santa Barbara, California, United States Recruiting
• Rocky Mountain Cancer Centers - Boulder /ID# 261203
  Boulder, Colorado, United States Recruiting
• Christiana Care Health Service /ID# 261207
  Newark, Delaware, United States Recruiting
• Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
  Jacksonville, Florida, United States Recruiting

+216 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Epcoritamab plus dose‑adjusted EPOCH‑R for aggressive B‑cell lymphoma

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• Epcoritamab with lenalidomide and rituximab for relapsed or refractory primary diffuse large B‑cell lymphoma of the CNS

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• Combination treatment for relapsed or refractory follicular lymphoma

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  Recruiting at 3 sites Phase 2 Peter MacCallum Cancer Centre, Australia · Camperdown, New South Wales and 5 other locations · NCT06414148

• Testing a new drug called odronextamab for treating follicular lymphoma

  This study is testing a new drug called odronextamab to see if it can safely and effectively treat people with follicular lymphoma who haven't received treatment before.

  Recruiting at 145 sites Phase 3 Regeneron Pharmaceuticals · Tucson, Arizona and 189 other locations · NCT06091254

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.