A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Venetoclax

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.