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Trial ID CA073-1022  |   NCT06425302

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 44
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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.
    1. Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
      1. Stage II to IV disease.
        1. Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.
          1. Bulky disease defined as:.
            1. 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).
          2. Presence of at least one of the following B symptoms:.
            1. Fever (>38°C) of unclear etiology.
            2. Night sweats.
            3. Weight loss greater than 10% within the prior 6 months.
          3. Splenomegaly with inferior margin below the umbilical line.
            1. Any one of the following cytopenia due to lymphoma:.
              1. Platelets <100,000 cells/mm3 (100 x 109/L).
              2. Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
              3. Hemoglobin < 10g/dL (6.25 mmol/L).
            2. Pleural or peritoneal serous effusion (irrespective of cell content).
              1. Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

              Exclusion Criteria

              Exclusion Criteria Icon
              • Clinical evidence of transformed lymphoma by investigator assessment.
                1. Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
                  1. Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Golcadomide Dose 1 + Rituximab

                      ASSIGNED INTERVENTION
                      • Drug: Golcadomide, Rituximab

                      Study Arms

                      Experimental: Golcadomide Dose 2 + Rituximab

                      ASSIGNED INTERVENTION
                      • Drug: Golcadomide, Rituximab

                      Study Arms

                      Experimental: Rituximab + Chemotherapy

                      ASSIGNED INTERVENTION
                      • Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Bendamustine
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