LBL-2016 for Children or Adolescents in China

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2031

Conditions
Lymphoblastic Lymphoma
Interventions
DRUG

Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine

Prednisone 60 mg/m2 per day,d1-28, then taper over 9 days; Vincristine 1.5 mg/m2 per day (max 2 mg),d1,8, 15, 22; Daunorubicin 30 mg/m2 per dose,d5,12,19; Pegylated-asparaginase 2000 IU/m2 per dose,d16,36,57; Cyclophosphamide 1000 mg/m2 per dose, d36, 57; Cytarabine 75 mg/m2 /d, d36-42,d 57-63; 6-Mercaptopurine 60 mg/m2 per day, d36-42, 57-63; Triple it, d8,29,36,57 1,8, 15, 22

DRUG

6-mercaptopurine,Methotrexate

6-Mercaptopurine 25 mg/m2 per day, d1-56; Methotrexate 5g/m2 per dose, d1, 15, 29, 43; Triple it, d1, 15, 29, 43;

DRUG

Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine

Dexamethasone 10 mg/m2 per day, d1-7, d15-21; Vincristine 1.5 mg/m2 per day (max 2 mg), d1, 8, 15; Doxorubicin 30 mg/m2 per dose, d1, 8, 15; Pegylated-asparaginase 2,000 IU/m2 per dose, d3, 24; Cyclophosphamide 1000 mg/m2 per dose, d29; Cytarabine 75 mg/m2 /d, d29-35; 6-Mercaptopurine 60 mg/m2 per day, d29-35; Triple it, d1, 29;

DRUG

Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Methotrexate

Dexamethasone 20mg/m2/day, d1-5; Vincristine 1.5 mg/m2 per day (max 2 mg), d1, 6; Methotrexate 5000mg/m2, d1; Cyclophosphamide 200mg/m2/dose, q12h×5, d2-4; Cytarabine 2000mg/m2/dose, ,q12h×2, d5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d1;

DRUG

Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginase

Dexamethasone 20mg/m2/day, d1-5; Vindesine 3mg/m2(MAX 5mg), d1, 6; Methotrexate 5000mg/m2, d1; Ifosfamide 800mg/m2/dose, q12h×5,d2-4; Daunorubicin 25mg/m2/dose, d5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d1;

DRUG

Dexamethasone, Cytarabine, Etoposide, Pegylated-asparaginase

Dexamethasone 20mg/m2/day, d1-5; Cytarabine 2000mg/m2/dose,q12h× 4, d1, 2; Etoposide 100mg/m2/dose,q12h×5, d3,4,5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d5;

DRUG

Methotrexate, 6-mercaptopurine

6-mercaptopurine 50 mg/m2 per day, Daily; Methotrexate 20 mg/m2 per dose, Once a week; Triple it, Once every 4 weeks for 12 times;

Trial Locations (2)

200127

Shanghai Children's Medical Center, Shanghai

Unknown

West China Second University Hospital, Chengdu

All Listed Sponsors
collaborator

Shanghai Children's Medical Center

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

West China Second University Hospital

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

collaborator

Children's Hospital of Soochow University

OTHER

collaborator

Nanjing Children's Hospital

OTHER

collaborator

Xiangya Hospital of Central South University

OTHER

lead

Children's Cancer Group, China

NETWORK