10
Participants
Start Date
May 15, 2018
Primary Completion Date
March 31, 2020
Study Completion Date
March 31, 2020
Alvocidib
ACM regimen:30 mg/60 mg, 30-minute intravenous (IV) infusion, followed 4-hour IV infusion from Day 1 to Day 3 A+7+3 regimen: recommended dose (RD), 30-minute IV infusion, followed 4-hour IV infusion from Day 1 to Day 3
Cytarabine
300 or 667 mg/m2/day, 72-hour continuous IV infusion starting on Day 6 (ACM regimen)
Mitoxantrone
14 or 40 mg/m2/day, IV infusion over 1 hour to 2 hours at 12 hours after the end of DSP-AraC administration (acceptable range + 3 hours)
Cytarabine
100 mg/m2/day, continuous IV infusion for 7 days from Day 5 to Day 11 (A+7+3 regimen)
Daunorubicine
60 mg/m2/day, 30-minute IV infusion for 3 days from Day 5 to Day 7
Fukui University Hospital, Yoshida-gun
Chugoku Central Hospital, Fukuyama
Hokkaido University Hospital, Sapporo
University of Tsukuba Hospital, Tsukuba
Tokai University Hospital, Isehara
Osaka City Hospital Organization, Miyakojima-ku
Kindai University Hospital, Sayama
NTT Medical Center Tokyo, Shinagawa-ku
Kyushu University Hospital, Fukuoka
National Hospital Organization Kyushu Medical Center, Fukuoka
Fukushima Medical University Hospital, Fukushima
Sumitomo Pharma Co., Ltd.
INDUSTRY