91
Participants
Start Date
January 31, 2009
Primary Completion Date
June 30, 2012
Study Completion Date
July 31, 2014
Nilotinib+mVPD
"1. Induction:~ * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~ * Vincristine 2 mg iv push (d1, 8, 15, 22)~ * Prednisolone 60 mg/m2/day po (d1-28)~ * Nilotinib 400mg bid/d (d8-)~2. Consolidation A (cycle1)~ * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~ * Vincristine 2 mg iv (d1, 8)~ * Prednisolone 60 mg/m2/day po (d1-14)~ * Nilotinib 400mg bid/d~3. Consolidation B (cycles 2\&4)~ * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~ * Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~ * Nilotinib 400mg bid/d~4. Consolidation C (cycles 3\&5)~ * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~ * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~ * Nilotinib 400mg bid/d~5. Maintenance~ ◦Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6. Consider alloHCT"
Daegu Fatima Hospital, Daegu
Kyungpook National University Hospital, Daegu
Yeungnam University Medical Center, Daegu
Daegu Catholic University Hospital, Daegu
Ulsan University Hospital, Ulsan
National Cancer Center - Korea, Goyang
Chonnam National University Hwasun Hospital, Jeollanam-do
Gyeongsang National University Hospital, Jinju
Pusan National University Hospital, Pusan
Inje University Seoul Paik Hospital, Seoul
Seoul National University Hospital, Seoul
Kyung Hee University Hospital, Seoul
Samsung Medical Center, Seoul
Asan Medical Center - University of Ulsan College of Medicine, Seoul
Konkuk University Medical Center, Seoul
Ajou University Hospital, Suwon
Lead Sponsor
Asan Medical Center
OTHER