AbbVie: M16-186 Ph1b Venetoclax and Alvocidib in R/R AML (Leukemia) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drugs, Venetoclax and Alvocidib, can be safely combined for use in patients with relapsed/refactory AML.

What is the Condition Being Studied?

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Who Can Participate in the Study?

Adults who:
- Have a diagnosis of R/R AML
- Do not have central nervous system leukemia
- Do not have severe chronic obstructive pulmonary disease (COPD) with hypoxemia
- Do not have any prior allogeneic stem cell transplant within 6 months of getting the study drug and no requirement for graft versus host therapy
- Do not have a history of taking alvocidib or any other CDK9 inhibitor
- Do not have any known gastrointestinal disorders
- Do not have an active, uncontrolled infection
- Do not have a known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

Age Group

What is Involved?

If you choose to join this study, you will:
- Have a screening visit to make sure it safe for you to be in this study
- Take Venetoclax once daily by mouth for 28 days and Alvocidib that will be given by iv infusion on day 1, 2 and 3 of all cycles
- Have a follow-up visit that will include follow up exams and other tests every month for 1 year

Study Details

Full Title
Phase 1b Study of Venetoclax and Alvocidib in Patients with Relapsed/Refractory Acute Myeloid Leukemia
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00091269
NCT: NCT03441555
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center