A Prospective Study for the Treatment of Children With Newly Diagnosed LCH Using a Cytarabine Contained Protocol

PHASE3RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2026

Conditions
Langerhans Cell Histiocytosis
Interventions
DRUG

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)

DRUG

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

DRUG

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

DRUG

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)

DRUG

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

DRUG

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

DRUG

Prednisone+vincristine

. Group 3 Continuation treatment (W7\~W52)Prednisone 40mg/m2 d1-5 q3w; Vincristine 1.5/m2 iv d1 q3w

OTHER

Local therapy

Local therapy/wait and see. Group 4

Trial Locations (1)

Unknown

RECRUITING

Shanghai Children's Medical Center, Shanghai

All Listed Sponsors
lead

Shanghai Children's Medical Center

OTHER