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Brief Title: A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Official Title: Phase 1b Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Study ID: NCT03797261
Brief Summary: This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL). This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope /ID# 207393, Duarte, California, United States
USC Norris Cancer Center /ID# 207396, Los Angeles, California, United States
University of Iowa Hospitals and Clinics /ID# 207459, Iowa City, Iowa, United States
Univ Kansas Med Ctr /ID# 207480, Kansas City, Kansas, United States
Duplicate_Dana-Farber Cancer Institute /ID# 207367, Boston, Massachusetts, United States
Washington University-School of Medicine /ID# 206995, Saint Louis, Missouri, United States
NYU Langone Medical Center /ID# 207390, New York, New York, United States
Unc /Id# 207388, Chapel Hill, North Carolina, United States
UPMC Hillman Cancer Ctr /ID# 208482, Pittsburgh, Pennsylvania, United States
Calvary Mater Newcastle /ID# 211455, Waratah, New South Wales, Australia
Royal Adelaide Hospital /ID# 210602, Adelaide, South Australia, Australia
Alfred Health /ID# 210350, Melbourne, Victoria, Australia
Universitaetsklinikum Frankfurt /ID# 207984, Frankfurt am Main, Hessen, Germany
Universitaetsklinikum Leipzig /ID# 209824, Leipzig, Sachsen, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 207987, Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 207803, Dresden, , Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 207788, Hamburg, , Germany
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR