A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
Inclusion Criteria
Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
Stage II to IV disease.
Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.
i) Bulky disease defined as:.
A. A nodal or extra nodal (except spleen) mass > 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than >3 cm).
ii) Presence of at least one of the following B symptoms:.
A. Fever (>38°C) of unclear etiology.
B. Night sweats.
C. Weight loss greater than 10% within the prior 6 months.
iii) Splenomegaly with inferior margin below the umbilical line.
iv) Any one of the following cytopenia due to lymphoma:.
A. Platelets <100,000 cells/mm3 (100 x 109/L).
B. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
C. Hemoglobin < 10g/dL (6.25 mmol/L).
v) Pleural or peritoneal serous effusion (irrespective of cell content).
vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).
Exclusion Criteria