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

  • Interventional
  • Not Recruiting
  • NCT03484520
Eligibility Details Visit Clinicaltrials.gov

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.

At a Glance

National Government IDNCT03484520

IRB#IRB18-0354

Lead SponsorAbbVie

Lead PhysicianMichael J. Thirman

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting