Active — Not RecruitingPhase 2

Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma

United States29 participantsStarted 2024-01-24

Plain-language summary

This phase II trial tests how well lenalidomide and epcoritamab works in treating patients with follicular lymphoma that has not been previously treated. Although follicular lymphoma is incurable, prognosis has improved for both early and advanced stage disease, largely attributed to therapeutic advances. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens (the part of the target that the antibody attaches to), at the same time. This dual action allows bispecific antibodies to improve target specificity by binding two antigens on the same cell to recruit and activate immune cells to kill cancer cells. Lenalidomide and epcoritamab, when given together, may be more effective in treating patients with follicular lymphoma than if they were given alone.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed previously untreated FL grade 1-3a, requiring therapy per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria * Radiologically measurable lymphadenopathy (\> 1.5 cm) or extranodal involvement (including spleen, bone marrow or other extranodal site) * Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 With bone marrow involvement: ANC ≥ 500/mm\^3 * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement * Without bone marrow involvement: Platelets ≥ 50,000/mm\^3 With bone marrow involvement: Platelets ≥ 25,000/mm\^3 * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement. * Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease) * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN * Creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula or creatinine level \< 1.5 mg/dL * If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN * If not receiving anticoagulants: Activated p…

What they're measuring

Complete response (CR) rate

Timeframe: Up to 2 years

Trial details

NCT IDNCT06112847

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-17