Status:
TERMINATED
A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Genentech, Inc.
Amgen
Conditions:
Acute Myeloid Leukemia
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Adequate kidney, liver and hematology values as described in the protocol.
- 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
- History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
- 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.
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03797261
Start Date
March 18 2019
End Date
December 30 2019
Last Update
December 7 2021
Active Locations (17)
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1
City of Hope /ID# 207393
Duarte, California, United States, 91010
2
USC Norris Cancer Center /ID# 207396
Los Angeles, California, United States, 90033
3
University of Iowa Hospitals and Clinics /ID# 207459
Iowa City, Iowa, United States, 52242
4
Univ Kansas Med Ctr /ID# 207480
Kansas City, Kansas, United States, 66160