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

Phase 3

Recruiting

• Conditions: Pediatric Anaplastic Large Cell Lymphoma
• Interventions: Drug: P regimen; Drug: Course A1 + Vin; Drug: Course B1 +Vin; Drug: Course A2 + Vin; Drug: Course B2 +Vin; Drug: Course A3 + Vin; Drug: Course B3 +Vin; Drug: Maintenance therapy

• Registration Number: NCT04881838
• Lead Sponsor: Children's Cancer Group, China

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High risk group	P regimen	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Course B1 +Vin	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Course A1 + Vin	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Course A2 + Vin	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Maintenance therapy	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Course A3 + Vin	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Course B3 +Vin	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement
High risk group	Course B2 +Vin	1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement

Primary Outcome Measures

Name	Time	Method
Treatment-related adverse events	Up to 3years	Number of participants with treatment-related adverse events as assessed by CTCAEv5.0
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

Secondary Outcome Measures

Name	Time	Method
Patient compliance	Up to 3years	the percentage of patients who complete the maintenance therapy of this modified ALCL99 regimens
Value of early PET/CT in pediatric ALCL	Up to 3 years	Prognostic value of early remission of PET/CT after 2 cycles of chemotherapy in pediatric ALCL
Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level in pediatric ALCL	Up to 3 years	Prognostic value of peripheral blood/bone marrow NPM-ALK or ALK-variants level (qPCR) at diagnosis in pediatric ALCL

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China