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Monoclonal Antibodies

Lenalidomide + Epcoritamab for Follicular Lymphoma

Phase 2
Recruiting
Led By Swetha Kambhampati
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Without bone marrow involvement: Platelets ≥ 50,000/mm^3
Histologically confirmed previously untreated FL grade 1-3a, requiring therapy per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests if lenalidomide and epcoritamab can treat follicular lymphoma, a type of cancer. This combo may be more effective than either alone.

Who is the study for?
Adults over 18 with untreated Follicular Lymphoma (FL) grade 1-3a who need treatment. They must have measurable lymphadenopathy or extranodal involvement, acceptable organ function tests, and for women of childbearing potential, a negative pregnancy test and agreement to use effective birth control. Excluded are those with certain heart conditions, active infections like hepatitis B/C or HIV, other recent malignancies, pregnant/breastfeeding women, and anyone unlikely to follow the study procedures.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining Lenalidomide (which affects the immune system and blood vessel growth in cancer cells) with Epcoritamab (a dual-action antibody that targets cancer cells more specifically). This phase II trial includes additional diagnostic procedures like bone marrow biopsy and imaging tests such as CT scans, MRIs, PET scans to monitor disease progression.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to Lenalidomide's modulation effect; allergic responses from Epcoritamab; fatigue; changes in blood counts leading to increased infection risk; possible liver issues reflected by altered enzyme levels. Specific experiences will vary among participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My platelet count is at least 50,000 without bone marrow issues.
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My follicular lymphoma is confirmed and needs treatment according to GELF criteria.
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I have swollen lymph nodes or cancer spread outside the lymph nodes that can be seen on scans.
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My white blood cell count is healthy.
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My platelet count is at least 25,000/mm^3 despite bone marrow involvement.
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My kidney function is good based on a creatinine clearance test.
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My blood clotting levels are within the normal range.
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My blood clotting time is within normal limits without taking blood thinners.
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I am a woman who can have children and my pregnancy test is negative.
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My white blood cell count is healthy.
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I am registered and agree to follow the Revlimid REMS program, including taking aspirin or another blood thinner.
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events (AEs)
Overall response rate (ORR)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (lenalidomide and epcoritamab)Experimental Treatment8 Interventions
Patients receive lenalidomide PO QD on days 1-21 of each cycle and epcoritamab SC on days 1, 8, 15, and 21 of cycles 1-3 and on day 1 of each subsequent cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients may be re-treated with study treatment at any point during the follow-up period as long as they did not progress during treatment or stop due to unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI as well as bone marrow biopsy throughout the trial. Patients undergo blood sample collection on trial and during follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Computed Tomography
2017
Completed Phase 2
~2720
Lenalidomide
2005
Completed Phase 2
~1070

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,513 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,287 Total Patients Enrolled
Swetha KambhampatiPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
36 Total Patients Enrolled
~18 spots leftby Oct 2025
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