A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Interventional
- Not Recruiting
- NCT03484520
Contact Information
Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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).
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.