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

NCT04881838 · tracked via the Priya Life Science China tracker

Sponsor

Children's Cancer Group, China

Phase

Phase 3

Started

2021-03-01

Last updated

2026-03-19

Condition(s) studied

Pediatric Anaplastic Large Cell Lymphoma

Investigational drug(s) / intervention(s)

P regimenCourse A1 + VinCourse B1 +VinCourse A2 + VinCourse B2 +VinCourse A3 + VinCourse B3 +VinMaintenance therapy

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

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;

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;

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;

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;

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;

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;

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

Study summary

A prospective study on the efficacy of modified ALCL99 regimens in the treatment of the current Chinese pediatric and adolescent high-risk ALCL and compared with our historical data.

Eligibility

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

Inclusion Criteria: * Patient must be ≤ 18 years at the time of diagnosis * Newly diagnosed patients with histologically confirmed high-risk anaplastic large cell lymphoma * No congenital immunodeficiency, HIV infection, or prior organ transplant Exclusion Criteria: * Patients have received prior cytotoxic chemotherapy/target therapy/radiation, if any steroid applied, total prior steroids dosage \> Dexamethasone 40 mg/m2 for the current diagnosis or any cancer * Patients have overwhelming infection, and a life expectancy of \< 2 weeks

Primary outcome measure(s)

3-year event free survival (EFS) — Up to 3 years
Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death
Treatment-related adverse events — Up to 3years
Number of participants with treatment-related adverse events as assessed by CTCAEv5.0

Trial sites (1)

Facility	City	Region	Status
Shanghai Children's Medical Center	Shanghai	China

More Children's Cancer Group, China trials in China

Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents Recruiting

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment Recruiting

LBL-2016 for Children or Adolescents in China Active, not recruiting

BNHL-2015 for Children or Adolescents in China Active, not recruiting

CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04881838 on ClinicalTrials.gov ↗ ← All trials in China