Acute Myeloid Leukemia (AML)
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must be = 18 years old, have newly diagnosed AML with intermediate or poor risk cytogenetics, have confirmation of CR or CRi following completion of intensive Induction and Consolidation chemotherapies; subject should be within one of the following time windows: have achieved first CR or CRi (after induction) within 120 days of the first dose of study drug (Cycle 1 Day 1) or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies until enrollment (Cycle 1 Day 1), and have an Eastern Cooperative Oncology Group (ECOG) performance status of = 2. The key laboratory requirements are as follows: Subject must meet the following laboratory parameters, per laboratory reference range within the screening period prior to study drug administration: - creatinine clearance = 30 mL/minute; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection; - bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: History of APL. History of active central nervous system involvement with AML. History of autologous stem cell transplantation for AML.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part I (Dose Confirmation): To determine the RPTD of venetoclax in combination with AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy Part III (Dose Finding): To determine the RPTD of venetoclax in combination with CC-486 as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy. Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol. ;Secondary Objective: Part 3 (Dose Finding) To characterize the safety, efficacy, pharmacokinetic (PK), and toxicity profiles of venetoclax in combination with CC-486 as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional chemotherapy. Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol. ;Primary end point(s): Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA Part III (Dose Finding): The primary endpoint is DLTs of venetoclax in combination with CC-486 Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol. ;Timepoint(s) of evaluation of this end point: Timepoint for part I: After approximately 20 subjects have been treated for at least 28 days Timepoint for part III: When RPTD has been reached. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol. ;Timepoint(s) of evaluation of this end point: Part 3 (Dose Finding) - Relapse free survival - Overall survival - Minimal residual disease conversion - Time to deterioration GHS/QoL scale from the EORTC QLQ-C30 - Change in global fatigue score from baseline to post-baseline using the PROMIS Fatigue SF-7a global fatigue score - Change from baseline to post-baseline in subscales and items from EORTC QLQ-C30 and EQ-5D-5L | — |
Countries
Australia, Austria, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Contact
AbbVie Deutschland GmbH & Co. KG
Outcome results
None listed