200
Participants
Start Date
July 1, 2018
Primary Completion Date
June 30, 2023
Study Completion Date
June 30, 2026
Prednisone+Cytarabine+vincristine
Group 1 initial treatment (W1\~W6). Prednisone 40mg/m2×4w, taper 2w; Vincristine 1.5mg/m2 iv d1 of w1,2,3,4,5,6; Cytarabine 100mg/m2 iv/IH d1-4 q2w (w1,3,5)
Prednisone+Cytarabine+vincristine+Mercaptopurine
Group 1 Consolidation continuation treatment (W7\~W22) . Prednisone 40mg/m2 d1-5 q3w (w7,10,13,16,19,22); VCR 1.5/m2 iv d1 q3w (w7,10,13,16,19,22); Cytarabine 100mg/m2 iv/IH d1-4 q3w (w7,10,13,16,19,22); 6-MP 50mg/m2/d,po,qn
Prednisone+Cytarabine+vincristine+Mercaptopurine
Group 1 Maintenance continuation treatment (W25\~52) . Prednisone 40mg/m2 d1-5 q3w; Vincristine 1.5/m2 iv d1 q3w; Cytarabine 100mg/m2 iv/IH d1-4 q6w ×3 times (w25,31,37); 6-MP 50mg/m2/d,po,qn
Prednisone+Cytarabine+vincristine
Group 2 Initial treatment (W1\~W6) . Prednisone 40mg/m2×4w, taper 2w; Vincristine 1.5mg/m2 iv d1 of w1,2,3,4,5,6; Cytarabine 100mg/m2 iv/IH d1-4 q2w (w1,3,5)
Prednisone+vincristine+Mercaptopurine
Group 2 continuation treatment (W7\~W52) . Prednisone 40mg/m2 d1-5 q3w; VCR 1.5/m2 iv d1 q3w; 6-MP 50mg/m2/d,po,qn
Prednisone+vincristine
Group 3 Initial treatment (W1\~W6) . Prednisone 40mg/m2×4w, taper 2w; Vincristine 1.5mg/m2 iv d1 of w1,2,3,4,5,6
Prednisone+vincristine
. Group 3 Continuation treatment (W7\~W52)Prednisone 40mg/m2 d1-5 q3w; Vincristine 1.5/m2 iv d1 q3w
Local therapy
Local therapy/wait and see. Group 4
RECRUITING
Shanghai Children's Medical Center, Shanghai
Shanghai Children's Medical Center
OTHER