A Phase 2, Randomized, Biomarker-driven, Clinical Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML

Protocol: 
AAAQ7667
Phase: 
II

A Phase 2, Randomized, Biomarker-driven, Clinical Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with an Exploratory Arm in Patients with Newly Diagnosed High-Risk AML

The purpose of this research study is to determine the effectiveness (how well something works) and safety of an “investigational” compound called alvocidib when used in a combination chemotherapy therapy regimen in patients with acute myeloid leukemia (AML) who test positive for NOXA priming.

Are you Eligible? (Inclusion Criteria)

Inclusion:
1) Be between the ages of >=18 and <=65 years
2) Be in first relapse (within 18 months of CR) or have primary refractory AML
(refractory to initial induction therapy using 1 or 2 cycles of intensive anthracycline/cytarabine ± etoposide induction)
3) Demonstrate NOXA BH3 priming of >=40% by mitochondrial profiling in bone marrow
4) Have a left ventricular ejection fraction (LVEF) >45% by echocardiogram
(ECHO) or multigated acquisition (MUGA) scan

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States