Actively Recruiting
Epcoritamab and Rituximab for First-line Follicular Lymphoma
Led by Reid Merryman, MD · Updated on 2025-12-23
100
Participants Needed
5
Research Sites
345 weeks
Total Duration
On this page
Sponsors
R
Reid Merryman, MD
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: * Rituximab (a type of monoclonal antibody therapy) * Epcoritamab (a T-cell bispecific antibody)
CONDITIONS
Official Title
Epcoritamab and Rituximab for First-line Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of CD20+ follicular lymphoma (grade 1-3A) without current or prior histologic transformation
- No prior systemic therapy for follicular lymphoma; prior radiation or short course steroids allowed
- Meets at least one modified GELF treatment criterion such as symptomatic adenopathy, organ impairment, constitutional symptoms, large tumor mass, multiple nodal sites, compressive symptoms, splenomegaly, effusions, leukemic phase, rapid progression, renal infiltration, or bone lesions
- No urgent need for cytoreductive chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Age 18 years or older
- Adequate blood counts and organ function according to specified laboratory thresholds
- Ability to understand and willingness to sign informed consent
- Willingness to provide a pre-treatment tumor sample by biopsy
- Willingness to abstain or use two effective contraceptive methods during and after study treatment as specified
You will not qualify if you...
- Requirement for systemic immunosuppressive therapy or prednisone dose over 10 mg daily
- Bulky cervical adenopathy causing or risking airway compression
- Stage I follicular lymphoma or candidates for curative radiation therapy
- Major surgery or significant injury within 4 weeks prior to study or unrecovered from surgery effects
- Active hepatitis B or C infection unless treated and undetectable
- Known HIV positivity when required by local standards
- Active infections or recent significant infections within 2 weeks prior to first dose
- Prior other malignancy unless disease-free for at least 2 years
- Immunization with live vaccines within one week prior or during study
- Severe/uncontrolled medical conditions limiting participation
- Recent serious cardiac events or diseases including heart failure with ejection fraction under 45%
- Inability to comply with hospitalization and study restrictions
- Pregnancy, breastfeeding, or intent to become pregnant
- Prior solid organ or allogeneic stem cell transplantation
- History or suspicion of hemophagocytic lymphohistiocytosis
- History of autoimmune diseases unless well controlled and approved
- Severe allergic reactions to anti-CD20 therapies or study drugs
- Vaccination with live vaccines within 28 days before first dose
- Active central nervous system lymphoma
- Neuropathy greater than grade 2
- Treatment with CAR-T therapy within 100 days prior
- Treatment with investigational drugs or certain chemotherapies within specified timeframes
- Active severe SARS-CoV-2 infection or recent exposure without negative tests
- Baseline ECG showing QTcF greater than 470 msec
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
5
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
R
Reid Merryman, MD
CONTACT
H
Heather A Walker, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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