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Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Primary Objectives To compare the complete response rate at 6 cycles after randomization as defined by centrally read PET/CT (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + TGR-1202 or obinutuzumab + lenalidomide) with obinutuzumab + CHOP in patients with early relapsing or refractory follicular lymphoma. Secondary Objectives a. (Primary Translational Medicine Objective): To validate the prognostic association of the m7-FLIPI model, demonstrating that the population of follicular lymphoma patients who respond poorly to chemoimmunotherapy are enriched for having a high-risk m7-FLIPI score, and that the score is associated with progression-free survival (integrated biomarker). b. To estimate the 30 month sustained complete response rate (CR30) defined by centrally read PET/CT with each of the regimens in this early relapsing or refractory follicular lymphoma population. c. To estimate best response at 12 cycles of therapy, progression free survival, duration of response and overall survival with each of the combinations in early relapsing or refractory follicular lymphoma. d. To evaluate the adverse effects of each of the regimens in early relapsing or refractory follicular lymphoma. e. To evaluate the predictive performance of non-invasive genotyping (m7-FLIPI in circulating tumor DNA) of plasma at study entry relative to standard tumor genotyping (m7-FLIPI) of formalin-fixed paraffin-embedded tumor tissue. f. To evaluate the association between the detection of active lymphoma by PET-CT and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy.

Primary Objectives To compare the complete response rate at 6 cycles after randomization as defined by centrally read PET/CT (integral biomarker) of 2 targeted therapeutic regimens (obinutuzumab + TGR-1202 or obinutuzumab + lenalidomide) with obinutuzumab + CHOP in patients with early relapsing or refractory follicular lymphoma. Secondary Objectives a. (Primary Translational Medicine Objective): To validate the prognostic association of the m7-FLIPI model, demonstrating that the population of follicular lymphoma patients who respond poorly to chemoimmunotherapy are enriched for having a high-risk m7-FLIPI score, and that the score is associated with progression-free survival (integrated biomarker). b. To estimate the 30 month sustained complete response rate (CR30) defined by centrally read PET/CT with each of the regimens in this early relapsing or refractory follicular lymphoma population. c. To estimate best response at 12 cycles of therapy, progression free survival, duration of response and overall survival with each of the combinations in early relapsing or refractory follicular lymphoma. d. To evaluate the adverse effects of each of the regimens in early relapsing or refractory follicular lymphoma. e. To evaluate the predictive performance of non-invasive genotyping (m7-FLIPI in circulating tumor DNA) of plasma at study entry relative to standard tumor genotyping (m7-FLIPI) of formalin-fixed paraffin-embedded tumor tissue. f. To evaluate the association between the detection of active lymphoma by PET-CT and the detection of circulating tumor DNA in plasma at baseline, after 6 and 12 cycles, and at 30 months after initiation of study therapy.