Clinical Trial TitleRandomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
National Clinical Trial Number:NCT04102020
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the safety and efficacy of venetoclax in combination with azacitidine (AZA) compared to best supportive care (BSC) as maintenance therapy in participants with Acute Myeloid Leukemia (AML) in first remission after conventional chemotherapy.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Have newly diagnosed AML with intermediate or poor risk cytogenetics.
- Have confirmed CR or CRi following completion of planned Induction and Consolidation chemotherapies.
- Have achieved first CR or CRi (after induction) within 120 days of enrollment or be no more than 75 days since last dose of conventional (including both Induction and Consolidation) chemotherapies until enrollment.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
The key laboratory requirements are as follows:
- Creatinine clearance ≥ 30 mL/minute; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
- Bilirubin < 3.0 × upper limit of normal (ULN) (adequate liver function) for Parts 1 and 2, or bilirubin < 2.0 × ULN for Part 3
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.