A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

Laborértékek

• Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.

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• Clinical evidence of transformed lymphoma by investigator assessment.
• Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
• Other protocol-defined Inclusion/Exclusion criteria apply.

• 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:.
  • Bulky disease defined as:.
• 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).
• Presence of at least one of the following B symptoms:.
• Fever (>38°C) of unclear etiology.
• Night sweats.
• Weight loss greater than 10% within the prior 6 months.
• Splenomegaly with inferior margin below the umbilical line.
• Any one of the following cytopenia due to lymphoma:.
• Platelets <100,000 cells/mm3 (100 x 109/L).
• Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
• Hemoglobin < 10g/dL (6.25 mmol/L).
• Pleural or peritoneal serous effusion (irrespective of cell content).
• Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).