Spots Global Cancer Trial Database for A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)
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Trial Identification
Brief Title: A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Official Title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study ID: NCT03135262
Study Description
Brief Summary: This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in combination with rituximab for DLBCL participants.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado, Aurora, Colorado, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Norton Cancer Institute - Dutchmans, Louisville, Kentucky, United States
Mount Sinai Medical Center, New York, New York, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Guthrie Clinic, Sayre, Pennsylvania, United States
Swedish Cancer Inst., Seattle, Washington, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Klinikum Augsburg, Augsburg, , Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
SLK-Kliniken Heilbronn GmbH, Heilbronn, , Germany
Klinikum rechts der Isar der TU München, München, , Germany
Universitätsklinikum Würzburg; Studienzentrale Hämatologie/Onkologie, Würzburg, , Germany
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Christchurch Hospital, Christchurch, , New Zealand
Auckland Clinical Studies Limited, Grafton, , New Zealand
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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