JRCT ID: jRCT2080225047
Registered date:03/02/2020
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M) [M19-708]
Basic Information
Recruitment status | completed |
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Health condition(s) or Problem(s) studied | Acute myeloid leukemia |
Date of first enrollment | 14/01/2020 |
Target sample size | 36 |
Countries of recruitment | Japan,Asia except Japan,North America,South America,Europe,Oceania |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : ABT-199 INN of investigational material : Venetoclax Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Venetoclax will be administered orally once daily starting on Day 1 of each 28-day cycle. control material(s) Generic name etc : Supportive care INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - |
Outcome(s)
Primary Outcome | Part 1 (Dose Confirmation) - The primary endpoint is DLTs of venetoclax in combination with AZA. Part 3 (Dose Finding) - The primary endpoint is DLTs of venetoclax in combination with oral AZA. |
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Secondary Outcome | safety efficacy pharmacokinetics Overall Survival (OS) Minimal Residual Disease (MRD) PRO |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Diagnosis of newly diagnosed AML. Subject meets the following disease activity criteria: confirmation of AML by the WHO criteria (2016) confirmation of CR or CRi following completion of intensive Induction and Consolidation chemotherapies (note: additional consolidation therapy on-study will be considered a protocol violation) subject should be within one of the following time windows: 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) AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria Eastern Cooperative Oncology Group (ECOG) performance status of <= 2. Subjects with adequate hematological, renal and liver function test values as described in the clinical trial protocol. |
Exclude criteria | No history of APL. No history of active central nervous system involvement with AML. |
Related Information
Primary Sponsor | AbbVie G.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | AbbVie Inc. |
Secondary ID(s) | NCT04102020,JapicCTI-205141 |
Contact
Public contact | |
Name | Patients and HCP Contact |
Address | 3-1-21 Shibaura, Minato-ku, Tokyo |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie GK |
Scientific contact | |
Name | Natsuko Satomi |
Address | 3-1-21 Shibaura, Minato-ku, Tokyo |
Telephone | +81-120-587-874 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie GK |