Clinical trial NCT04881838: CCCG-ALCL-2020 for Chinese Children and Adolescents with Newly Diagnosed High-risk ALCL
Official title: Using a Modified ALCL99 Regimen for Chinese Children with Newly Diagnosed High-risk Anapestic Large Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pediatric Anaplastic Large Cell Lymphoma
Keywords: Anapestic Large Cell Lymphoma
vinorelbine
pediatric
treatment outcome
Chinese
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
Collaborators: name: Shanghai Children's Medical Center
name: Nanjing Children's Hospital
name: Qilu Hospital of Shandong University
name: Tianjin Cancer Hospital
name: West China Second University Hospital
name: Xiangya Hospital
name: 1st Affiliated Hospital of Zhengzhou University
name: Shenzhen Children's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2021-05-11
Enrollment: 172
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All enrolled patients stratified into high risk group are assigned to one treatment regimen
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: 3-year event free survival (EFS)
timeFrame: Up to 3 years
measure: Treatment-related adverse events
timeFrame: Up to 3years
Secondary outcomes:
measure: Patient compliance
timeFrame: Up to 3years
measure: Value of early PET/CT in pediatric ALCL
timeFrame: Up to 3 years
measure: Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level in pediatric ALCL
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yijin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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