Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
- Conditions
- Acute Myeloid Leukemia (AML)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002217-19-DE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 112
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 Inductiion and Consolidation chemotherapies; subject should be within one of the following time windows:
have achieved first CR + 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 < 3.0 × upper limit of normal (ULN) (adequate liver function) for Parts 1 and 2, or bilirubin < 2.0 x ULN for Part 3; unless due to Gilbert's Syndrome;
•absolute neutrophil count = 1,500/µL;
•platelets = 100,000/µL.
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 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51
History of APL.
History of active central nervous system involvement with AML.
History of autologous stem cell transplantation for AML.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method