Acute Myeloid Leukemia Clinical Trial
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Summary
An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria:
Known central nervous system leukemia
Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.
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There are 13 Locations for this study
Little Rock Arkansas, 72205, United States
Los Angeles California, 90095, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43210, United States
Houston Texas, 77030, United States
SouthPort Queensland, 4215, Australia
Hobart Tasmania, 7000, Australia
Melbourne Victoria, 3168, Australia
Madrid , 28034, Spain
Salamanca , 37711, Spain
Valencia , 46026, Spain
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