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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 MĂźnchen, MĂźnchen, , Germany

Universitätsklinikum Wßrzburg; Studienzentrale Hämatologie/Onkologie, Wßrzburg, , 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

Useful links and downloads for this trial

Clinicaltrials.gov

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