The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Specified dose on specified days
Specified dose on specified days
Local Institution - 104
Stanford, California, United States
Local Institution - 110
Denver, Colorado, United States
Local Institution - 105
Boston, Massachusetts, United States
Maximum Tolerated Dose (MTD)
Time frame: Up to 42 days after first dose
Incidence of type of adverse events (AEs)
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of frequency of AEs
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of severity of AEs
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of relationship of AEs to study treatment
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Time frame: Up to approximately 12 months
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Local Institution - 106
New York, New York, United States
Local Institution - 113
New York, New York, United States
Local Institution - 102
Cleveland, Ohio, United States
Local Institution - 111
Oklahoma City, Oklahoma, United States
Local Institution - 101
Houston, Texas, United States
Local Institution - 202
North Melbourne, Victoria, Australia
Local Institution - 201
Melbourne, Australia
Overall Response Rate (ORR)
Time frame: Up to approximately 12 months
Minimal Residual Disease (MRD) Response Rate
Time frame: Up to approximately 12 months
MRD Conversion Rate
Time frame: Up to approximately 12 months
Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
Time frame: Up to approximately 12 months