A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies
Stopped early · Phase 1
Conditions studied: Acute Myeloid Leukemia, Non-Hodgkin's Lymphoma, Diffuse Large B-cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03797261
- Run by
- AbbVie
- People needed
- 9
- Starts
- 2019-03-18
- Expected to finish
- 2019-12-30
- Last updated by the study team
- 2021-12-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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