EUCTR2019-002217-19-ITActive, not recruitingPhase 1
Randomized, 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) - na
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subject must be = 18 years old, have newly diagnosed AML with intermediate or adverse risk cytogenetics, have confirmed CR or CRi following completion of planned induction and consolidation chemotherapy, have achieved first CR + CRi within 4 months of enrollment or no more than 75 days since last dose of conventional chemotherapy, and 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);
- •absolute neutrophil count = 1,500/µL;
- •platelets = 100,000/mm3.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
- •History of APL.
- •History of active central nervous system involvement with AML.
Investigators
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