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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

Must not have

Asymptomatic prostate cancer managed with 'watch and wait' strategy or hormonal therapy

Females only: Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the final dose of all study drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer is being monitored or treated with hormones.

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I am not pregnant, breastfeeding, nor plan to become pregnant soon.

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I had skin cancer (not melanoma) or melanoma in situ, but it's now treated with no signs of the disease.

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I do not have serious heart problems or recent heart attacks.

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I have not received any live vaccines in the last 4 weeks.

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My lymphoma has spread to my brain or spinal cord.

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My condition is grade 3b or transformed follicular lymphoma.

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I currently have an untreated or uncontrolled infection.

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I have at least one cancer lesion that hasn't been treated with radiation.

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I have had cancer before, but it's not currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete response (CR) rate

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events (AEs)

Overall response rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030