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Brief Title: A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official Title: Phase 1/2 Study to Determine the Safety, Pharmacokinetics, and Efficacy of Single Agent CC-122 and the Combinations CC-122 AND Ibrutinib and CC-122 and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study ID: NCT02406742
Brief Summary: Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab. CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience.
Detailed Description: The primary objectives of this Phase 1/2 Study are to determine the safety of single agent CC-122 and the safety, tolerability, and RP2D of CC-122 when administered in combination with ibrutinib and in combination with obinutuzumab to subjects with CLL/SLL. The secondary objectives are to evaluate the PK profiles of subjects administered CC-122 in combination with ibrutinib and in combination with obinutuzumab, to determine ibrutinib concentrations when given alone and in combination with CC-122 and to evaluate the preliminary efficacy of CC-122 at selected dose levels/regimens.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California San Diego, La Jolla, California, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Weill Cornell Medical College Dr. Feldman's Office, New York, New York, United States
Ohio State University Medical CenterJames Cancer Hospital, Columbus, Ohio, United States
The West Clinic, Memphis, Tennessee, United States
MD Anderson Cancer Center The University of Texas, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University Hospital Innsbruck, Innsbruck, , Austria
University Hospital of Salzburg St Johanns Spital, Salzburg, , Austria
Allgemeines Krankenhaus Wien, Wien, , Austria
Universitaetsklinikum EssenInnere Klinik und Poliklinik, Essen, , Germany
University of Schleswig-Holstein, Kiel, , Germany
Universitat zu Koln, Köln, , Germany
Universitatsklinikum Würzburg, Würzburg, , Germany
Fondazione Centro San Raffaele del Monte Tabor, Milano, , Italy
Ospedale Niguarda Milano, Milano, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Istituto Clinico Humanitas, Rozzano (MI), , Italy
Hospital Universitario Vall D hebron, Barcelona, , Spain
Fundacion Jimenez Daaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Name: Vijaya Kesanakurthy, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR