Leukemia, Myeloid, Acute
Conditions
Keywords
Acute Myeloid Leukemia, CC-486, Onureg, oral azacitidine, venetoclax, Venclexta, Venclyxto
Brief summary
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.
Interventions
DRUGCC-486
Specified dose on specified days
DRUGVenetoclax
Specified dose on specified days
Sponsors
AbbVie
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmation of the following for Acute Myeloid Leukemia (AML) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities * Agree to serial bone marrow aspirate/biopsies
Exclusion criteria
* Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype * Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy * Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | From informed consent form (ICF) signature to 28 days after last dose of study drug |
| Incidence of severity of AEs | From informed consent form (ICF) signature to 28 days after last dose of study drug |
| Incidence of relationship of AEs to study treatment | 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 | 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 | From informed consent form (ICF) signature to 28 days after last dose of study drug |
| Maximum Tolerated Dose (MTD) | Up to 42 days after first dose |
| Incidence of type of adverse events (AEs) | From informed consent form (ICF) signature to 28 days after last dose of study drug |
| Incidence of frequency of AEs | From informed consent form (ICF) signature to 28 days after last dose of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh) | Up to approximately 12 months |
| Overall Response Rate (ORR) | Up to approximately 12 months |
| Minimal Residual Disease (MRD) Response Rate | Up to approximately 12 months |
| MRD Conversion Rate | Up to approximately 12 months |
| Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi) | Up to approximately 12 months |
Countries
Australia, United States
Outcome results
None listed