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Hématologie / cancers du sang
CA073-1022
Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Golcadomide in Combination with Rituximab in Patients with Newly Diagnosed Advanced-Stage Follicular Lymphoma (GOLSEEK-2)"
- Open at Saint-Cloud since : 20/12/2024
- Target : Adult
- Phase : Phase II
Trial description
The main objective of this study is to assess whether two drugs, Golcadomide and Rituximab, are effective together in treating patients newly diagnosed with advanced-stage follicular lymphoma.;**Primary objective:**;- Evaluate the Complete Metabolic Response (CMR). This means that at the end of the treatment, no signs of cancer are detected during the examinations.;**Secondary objectives:**;- Assess the safety of the combination of Golcadomide at two doses with Rituximab.;- Determine the optimal dose of the combination to use in a larger study.;- Evaluate the overall response to treatment and the duration of this response.;- Assess Progression-Free Survival (PFS), which refers to the time from the start of the study until the cancer worsens or the patient dies, whichever comes first.;- Evaluate the efficacy of Golcadomide in combination with Rituximab by analyzing Overall Survival (OS). This refers to the time from the start of the study until the patient dies.;- Evaluate the efficacy of Rituximab in combination with chemotherapy in participants with newly diagnosed advanced-stage follicular lymphoma by analyzing the CMR and its response duration.
Url of the trialMain investigator
