A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
- Registration Number
- NCT04887857
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CC-486 in combination with Venetoclax CC-486 - CC-486 in combination with Venetoclax Venetoclax -
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) Up to 42 days after first dose 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: Urinalysis tests From informed consent form (ICF) signature to 28 days after last dose of study drug 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 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 Incidence of severity of AEs 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
- Secondary Outcome Measures
Name Time Method 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 Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh) Up to approximately 12 months
Trial Locations
- Locations (10)
Local Institution - 105
🇺🇸Boston, Massachusetts, United States
Local Institution - 102
🇺🇸Cleveland, Ohio, United States
Local Institution - 201
🇦🇺Melbourne, Australia
Local Institution - 202
🇦🇺North Melbourne, Victoria, Australia
Local Institution - 106
🇺🇸New York, New York, United States
Local Institution - 110
🇺🇸Denver, Colorado, United States
Local Institution - 104
🇺🇸Stanford, California, United States
Local Institution - 113
🇺🇸New York, New York, United States
Local Institution - 101
🇺🇸Houston, Texas, United States
Local Institution - 111
🇺🇸Oklahoma City, Oklahoma, United States