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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2029
  • participants needed
    172
  • sponsor
    Children's Cancer Group, China
Updated on 7 October 2022

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.

Description

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.

Details
Condition Pediatric Anaplastic Large Cell Lymphoma
Treatment maintenance therapy, P regimen, Course A1 + Vin, Course B1 +Vin, Course A2 + Vin, Course B2 +Vin, Course A3 + Vin, Course B3 +Vin
Clinical Study IdentifierNCT04881838
SponsorChildren's Cancer Group, China
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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