Study on Lenalidomide and Epcoritamab for Treating Untreated Follicular Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06112847

Provider View

This clinical trial is exploring how well the combination of lenalidomide and epcoritamab works in patients with follicular lymphoma who have not received any prior treatment. The study aims to see if these drugs together can be more effective than when used separately.

Patient Parameters

Program Overview

This phase II study is testing a new treatment for follicular lymphoma, a type of cancer that affects the lymphatic system. The treatment combines two drugs: lenalidomide, which can help the immune system fight cancer and stop cancer cells from growing, and epcoritamab, an antibody that helps the immune system target and destroy cancer cells. The goal is to see if using these drugs together can better control the disease in patients who have not been treated before.

Description

The main goal of this study is to see how effective the combination of lenalidomide and epcoritamab is in achieving a complete response in patients with newly diagnosed follicular lymphoma. Researchers will also look at other measures of effectiveness, such as how long patients stay free from disease progression and the duration of their response to treatment. Additionally, the study will monitor any side effects and explore how the treatment affects certain immune cells and genetic factors.

Participants will take lenalidomide by mouth daily for 21 days in each 28-day cycle and receive epcoritamab injections on specific days during the first three cycles and then once per cycle. The treatment can continue for up to 12 cycles unless the disease progresses or side effects become too severe. Throughout the study, participants will undergo various scans and tests, including blood tests and bone marrow biopsies, to monitor their response to treatment. After completing the treatment, participants will have follow-up visits to check for safety and monitor their health every six months for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating they are fully active or able to carry out light work.
  • Must have a confirmed diagnosis of untreated follicular lymphoma requiring treatment.
  • Must have measurable lymph node enlargement or involvement of other areas like the spleen or bone marrow.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified period after.
  • Must be willing to comply with the study's requirements, including participation in the Revlimid REMS program.

Exclusion Criteria

  • Have received any prior treatment for follicular lymphoma, except for certain low-dose radiation treatments.
  • Are currently enrolled in another treatment study.
  • Have received live vaccines within four weeks before starting the study.
  • Have lymphoma that has spread to the central nervous system.
  • Have a more aggressive form of follicular lymphoma.
  • Have a history of other cancers, unless they have been in remission for at least two years or are certain non-threatening types.
  • Have uncontrolled infections or certain viral infections like active hepatitis B or C.
  • Have significant heart disease or other serious medical conditions.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study or within six months after.
  • Have any condition that the study doctor believes would make participation unsafe or difficult.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.