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Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma


Active: Yes
Cancer Type: Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
NCT ID: NCT05409066
Trial Phases: Phase III Protocol IDs: M20-638 (primary)
NCI-2022-09448
2021-000169-34
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Genmab
NCI Full Details: http://clinicaltrials.gov/show/NCT05409066

Summary

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type
of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional
treatment and the disease recurs in almost all patients. This study will assess how safe
and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in
treating adult participants with relapsed or refractory (R/R) FL. Adverse events and
change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study
doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives
a different treatment. Enrollment to one of the groups is closed. Around 500 adult
participants with R/R FL will be enrolled in approximately 300 sites across the world.

Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles
and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with
subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.