Randomized, Open-label, 2-Arm, Multicenter, Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
- Conditions
- Acute Myeloid Leukemia (AML)MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002217-19-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 360
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
History of APL.
History of active central nervous system involvement with 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