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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Vijaya Kesanakurthy, MD

Affiliation: Celgene

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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