CCCG-ALCL-2020 for Chinese Children and Adolescents with Newly Diagnosed High-risk ALCL

PHASE3RecruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

March 1, 2026

Study Completion Date

March 1, 2029

Conditions
Pediatric Anaplastic Large Cell Lymphoma
Interventions
DRUG

P regimen

Dexamethasone 5 mg/m2 Days 1 and 2; 10mg/m2 Day 3 to 5; Cyclophosphamide 200 mg/m2 Days 1 and 2 Intrathecal therapy Day 1

DRUG

Course A1 + Vin

vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;

DRUG

Course B1 +Vin

vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;

DRUG

Course A2 + Vin

vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;

DRUG

Course B2 +Vin

vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;

DRUG

Course A3 + Vin

vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;

DRUG

Course B3 +Vin

vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;

DRUG

Maintenance therapy

Vinorelbine 25 mg/m2 IV, weekly for 3 consecutive weeks followed by 1-week rest. Totally 80 cycles.

Trial Locations (1)

Unknown

RECRUITING

Shanghai Children's Medical Center, Shanghai

All Listed Sponsors
collaborator

Shanghai Children's Medical Center

OTHER

collaborator

Nanjing Children's Hospital

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Tianjin Cancer Hospital

UNKNOWN

collaborator

West China Second University Hospital

OTHER

collaborator

Xiangya Hospital

OTHER

collaborator

1st Affiliated Hospital of Zhengzhou University

UNKNOWN

collaborator

Shenzhen Children's Hospital

OTHER_GOV

collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

lead

Children's Cancer Group, China

NETWORK