Spots Global Cancer Trial Database for A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
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Trial Identification
Brief Title: A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
Official Title: A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of Twice Daily Oral Midostaurin in Combination With Daunorubicin/Cytarabine Induction, High-dose Cytarabine Consolidation, and Midostaurin Single Agent Continuation Therapy in Newly Diagnosed Patients With FLT3-mutated Acute Myeloid Leukemia (AML).
Study ID: NCT03280030
Conditions
Study Description
Brief Summary: This study will evaluate the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid leukemia (AML).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Nagoya-city, Aichi, Japan
Novartis Investigative Site, Toyoake city, Aichi, Japan
Novartis Investigative Site, Kashiwa, Chiba, Japan
Novartis Investigative Site, Fukuoka city, Fukuoka, Japan
Novartis Investigative Site, Fukushima city, Fukushima, Japan
Novartis Investigative Site, Sapporo, Hokkaido, Japan
Novartis Investigative Site, Isehara, Kanagawa, Japan
Novartis Investigative Site, Kochi city, Kochi, Japan
Novartis Investigative Site, Nagasaki-city, Nagasaki, Japan
Novartis Investigative Site, Okayama city, Okayama, Japan
Novartis Investigative Site, Osaka Sayama, Osaka, Japan
Novartis Investigative Site, Osaka-city, Osaka, Japan
Novartis Investigative Site, Hamamatsu, Shizuoka, Japan
Novartis Investigative Site, Shimotsuke, Tochigi, Japan
Novartis Investigative Site, Bunkyo ku, Tokyo, Japan
Novartis Investigative Site, Bunkyo-ku, Tokyo, Japan
Novartis Investigative Site, Shinagawa ku, Tokyo, Japan
Novartis Investigative Site, Aomori, , Japan
Novartis Investigative Site, Fukuoka, , Japan
Novartis Investigative Site, Kyoto, , Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Yamagata, , Japan
Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Kirov, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Samara, , Russian Federation
Novartis Investigative Site, St Petersburg, , Russian Federation
Novartis Investigative Site, Putzu City, Chiayi Hsien, Taiwan
Novartis Investigative Site, Kaohsiung City, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taoyuan, , Taiwan
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Hanoi, , Vietnam
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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