A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
NCT ID: NCT03797261
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
9 participants
INTERVENTIONAL
2019-03-18
2019-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Venetoclax + AMG 176
Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored.
Venetoclax
tablet, oral
AMG 176
solution, intravenous
Interventions
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Venetoclax
tablet, oral
AMG 176
solution, intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL) confirmed by the World Health Organization (WHO) criteria, as appropriate.
* Meets the following disease activity criteria:
* AML: must have received at least 1 prior therapy for AML and be ineligible for cytotoxic therapy and allogeneic stem cell transplant.
* NHL/DLBCL: measurable disease with a bidimensional lesion measuring at least 1.5 cm; received at least 1 prior therapy for NHL with no curative treatment option as determined by the investigator and be ineligible for a stem cell transplant.
Exclusion Criteria
* History of of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ.
* Prior allogeneic stem cell transplant or autologous stem cell transplant within 100 days of study drug administration and no signs or symptoms of acute or chronic graft-versus-host disease.
* Previous enrollment in a randomized trial including either venetoclax or AMG 176.
* Known active or chronic pancreatitis; severe chronic obstructive pulmonary disease with hypoxemia; central nervous system manifestations of malignancy.
* Active, uncontrolled infection.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Amgen
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
St 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, Hesse, Germany
Universitaetsklinikum Leipzig /ID# 209824
Leipzig, Saxony, 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
Countries
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Related Links
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Related Info
Other Identifiers
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2018-003314-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-785
Identifier Type: -
Identifier Source: org_study_id
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