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

Children's Cancer Group, China

Status and phase: Enrolling; Phase 3

Conditions: Pediatric Anaplastic Large Cell Lymphoma

Treatments: Drug: Course B1 +Vin; Drug: P regimen; Drug: Course B3 +Vin; Drug: Course A3 + Vin; Drug: Course A2 + Vin; Drug: Course A1 + Vin; Drug: Course B2 +Vin; Drug: Maintenance therapy

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04881838

CCCG-ALCL-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

172 participants in 1 patient group

High risk group

Experimental group

Description:

1. Stage I, unresected; Stage I with "B" syndrome 2. Stage II 3. Stage III 4. Stage IV without CNS involvement

Treatment:

Drug: Maintenance therapy

Drug: Course B2 +Vin

Drug: Course A1 + Vin

Drug: Course A3 + Vin

Drug: Course A2 + Vin

Drug: Course B3 +Vin

Drug: P regimen

Drug: Course B1 +Vin