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Active, not recruiting

NCT Number: NCT04881838

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pediatric Anaplastic Large Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Children's Medical Center

Shanghai, China

About this study

Anaplastic large cell lymphoma (ALCL) accounts for 15% of pediatric and adolescent non-Hodgkin lymphomas (NHLs). In our historical study (retrospective multicenter study), the 3-year event-free survival (EFS) was 65% for 80 eligible patients treated in 10 centers between January 2009 and June 2014.

The ALCL99 trial reported a 2-year overall survival of 92% and 2-year event-free survival of 74% then become the current standard frontline treatment for pediatric ALCL. The recent long-term follow-up data from ALCL99 trial highlighted its excellent outcome. A less toxic schedule of methotrexate (MTX) 3g/m2 in a 3-hour infusion without intrathecal therapy reproduced the favorable results from previous reports of NHL-BFM90 protocol with MTX at 1g/m2 in a 3-hour infusion. Additionally, a prospective ALCL-Relapse trial by the European Inter-Group for Childhood Non-Hodgkin Lymphoma demonstrated 80% of patients with a late relapse can be cured by 24 months of vinblastine monotherapy. However, vinblastine would not be advised as a treatment option in mainland China due to its inaccessibility. A pilot experience using single-drug vinorelbine in 4 pediatric patients with relapsed ALCL with satisfactory outcome provides the rational for studying vinorelbine as a front line drug option.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P regimen

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. 3-year event free survival (EFS)

    Time frame: Up to 3 years

    Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death

  2. Treatment-related adverse events

    Time frame: Up to 3years

    Number of participants with treatment-related adverse events as assessed by CTCAEv5.0

Secondary outcomes

  1. Patient compliance

    Time frame: Up to 3years

    the percentage of patients who complete the maintenance therapy of this modified ALCL99 regimens

  2. Value of early PET/CT in pediatric ALCL

    Time frame: Up to 3 years

    Prognostic value of early remission of PET/CT after 2 cycles of chemotherapy in pediatric ALCL

  3. Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level in pediatric ALCL

    Time frame: Up to 3 years

    Prognostic value of peripheral blood/bone marrow NPM-ALK or ALK-variants level (qPCR) at diagnosis in pediatric ALCL

Sponsors and collaborators

Lead sponsor

Children's Cancer Group, China

Network

Collaborators

  • Nanjing Children's Hospital
  • Qilu Hospital of Shandong University
  • Shanghai Children's Medical Center
  • Shenzhen Children's Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The First Affiliated Hospital of Zhengzhou University
  • Tianjin Cancer Hospital
  • West China Second University Hospital
  • Xiangya Hospital

Registry information

Official study title

Using a Modified ALCL99 Regimen for Chinese Children With Newly Diagnosed High-risk Anapestic Large Cell Lymphoma

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
May 11, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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