NIPH Clinical Trials Search

study to evaluate the efficacy and safety in newly diagnosed patients with FLT3-mutated acute myeloid leukemia (AML)

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	acute myeloid leukemia (AML)
Date of first enrollment	06/04/2018
Target sample size	36
Countries of recruitment	Japan,Asia except Japan,North America
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome	safety efficacy
Secondary Outcome	safety efficacy

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 64age old
Gender	Both
Include criteria	Patients eligible for inclusion in this study must meet all of the following eligibility criteria: 1.Diagnosis of AML (>= 20% blasts in the bone marrow based on WHO 2016 classification (Arber et al 2016). Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible 2.Documented presence of an ITD and/or TKD activating mutation in the FLT3 gene, as determined by analysis in a Novartis designated laboratory The other inclusion criteria specified in the clinical trial protocol also apply
Exclude criteria	Patients eligible for this study must not meet any of the following criteria: 1.Neurologic symptoms suggestive of CNS leukemia unless CNS leukemia has been excluded by a lumbar puncture. Patients with CSF fluid positive for AML blasts are not eligible. 2.Developed therapy-related AML after prior radiotherapy (RT) or chemotherapy for another cancer or disorder 3.Isolated extramedullary leukemia (please refer to Section 7.2.2.1) 4.Known hypersensitivity to midostaurin, cytarabine or daunorubicin or to any of the excipients of midostaurin/placebo, cytarabine or daunorubicin 5.Any investigational agent within 30 days or 5 half-lives, whichever is greater, prior to Day 1. An investigational agent is defined as an agent with no approved medical use in adults or in pediatric patients The other inclusion criteria specified in the clinical trial protocol also apply.