Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

June 30, 2012

Study Completion Date

July 31, 2014

Conditions
Leukemia
Interventions
DRUG

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"

Trial Locations (16)

701-600

Daegu Fatima Hospital, Daegu

702-701

Kyungpook National University Hospital, Daegu

712-749

Yeungnam University Medical Center, Daegu

Unknown

Daegu Catholic University Hospital, Daegu

Ulsan University Hospital, Ulsan

410-769

National Cancer Center - Korea, Goyang

519-809

Chonnam National University Hwasun Hospital, Jeollanam-do

660-701

Gyeongsang National University Hospital, Jinju

602-739

Pusan National University Hospital, Pusan

100-032

Inje University Seoul Paik Hospital, Seoul

110-744

Seoul National University Hospital, Seoul

130-702

Kyung Hee University Hospital, Seoul

135-710

Samsung Medical Center, Seoul

138-736

Asan Medical Center - University of Ulsan College of Medicine, Seoul

143-729

Konkuk University Medical Center, Seoul

441-749

Ajou University Hospital, Suwon

Sponsors
All Listed Sponsors
lead

Asan Medical Center

OTHER

NCT00844298 - Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter