NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedAcute myeloid leukemia
Date of first enrollment14/01/2020
Target sample size36
Countries of recruitmentJapan,Asia except Japan,North America,South America,Europe,Oceania
Study typeInterventional
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 OutcomePart 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.
Secondary Outcomesafety efficacy pharmacokinetics Overall Survival (OS) Minimal Residual Disease (MRD) PRO

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaDiagnosis 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 criteriaNo history of APL. No history of active central nervous system involvement with AML.

Related Information

Contact

Public contact
Name Patients and HCP Contact
Address 3-1-21 Shibaura, Minato-ku, Tokyo
Telephone +81-120-587-874
E-mail 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
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie GK