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Brief Title: A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.
Official Title: A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 in Combination With Obinutuzumab (GA101) in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Indolent Non-Hodgkin's Lymphoma
Study ID: NCT02417285
Brief Summary: CC-122-NHL-001 study is a multicenter, open-label, phase Ib study with dose escalation and expansion parts. It evaluates the safety, tolerability and clinical pharmacokinetics of CC-122 in combination with obinutuzumab (GA101). The study is also assessing the preliminary efficacy of the combination as well as pharmacodynamic and tumor biomarkers as exploratory objectives. In the dose escalation part, the safety and tolerability of increasing doses of CC-122 administered with a fixed dose of obinutuzumab will be administered to identify the maximum tolerated dose. In the dose expansion part, more patients will be enrolled at a CC-122 dose selected from the escalation part of the study in combination with fixed dose obinutuzumab to further study safety and efficacy.
Detailed Description: The one or two cohorts during the dose expansion phase (Part B) will enroll subjects with relapsed or refractory follicular lymphoma (FL) who were either refractory to or relapsed after treatment with a lenalidomide-containing regimen (FL-1 cohort) or never been exposed to lenalidomide (FL-2 cohort). The FL-1 and FL-2 cohorts will enroll up to 20 and/or up to 30 subjects, respectively.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 105, Borddeaux Cedex, , France
Local Institution - 102, Marseille cedex, , France
Local Institution - 103, Pierre-Benite CEDEX, , France
Local Institution - 101, Villejuif CEDEX, , France
Local Institution - 301, Bologna, , Italy
Local Institution - 302, Torino, , Italy
Local Institution - 201, Amsterdam, , Netherlands
Local Institution - 202, Rotterdam, , Netherlands
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR