A study comparing the efficacy and safety of golcadomid in combination with rituximab (Golca + R) versus the investigator’s choice in participants with relapsed/refractory follicular lymphoma

Follicular lymphoma is a rare form of slow-growing lymphoma that primarily affects the immune system. It develops as a result of changes in certain white blood cells (B cells), which multiply uncontrollably. The disease may return after treatment (recur) or may not respond to therapy (be refractory). Standard first-line treatments usually consist of a combination of antibodies such as rituximab with chemotherapy (e.g., CHOP or bendamustine). The antibody rituximab specifically targets and destroys B cells, while chemotherapy generally targets rapidly dividing cells in the body (e.g., cancer cells) and prevents or delays cell growth. If the disease recurs or does not respond to treatment, further treatment options become necessary. The study drug, golcadomid, is an immunomodulator that activates the immune system against cancer cells.

The goal of this Phase 3 study is to compare a new combination of golcadomid and rituximab with the current standard of care, known as the “investigator’s choice of therapy.” This may be either rituximab plus lenalidomide (an immunomodulator) or a combination of chemotherapy with rituximab (e.g., R-CHOP or rituximab + bendamustine). The study is open-label (unblinded) and randomized—meaning that assignment to a treatment group is random, and both patients and medical staff know which treatment is being administered. Approximately 400 patients worldwide are expected to participate.

Women and men aged 18 and older with histologically confirmed follicular lymphoma (grade 1–3a) who have previously received treatment with at least one combination of a B-cell antibody and an alkylating chemotherapeutic agent (e.g., rituximab + bendamustine/CHOP) and are in good general health may participate in the study. In addition, measurable and PET-positive disease foci must be detected. Patients with other types of lymphoma, central nervous system involvement, serious pre-existing conditions, or multiple resistances to standard treatments are excluded.