Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, T-Cell

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Dexamethasone

Etoposide

Vinorelbine

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Methotrexate

Ifosfamide

Dexamethasone acetate

Etoposide phosphate

Isophosphamide mustard

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

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

P regimen

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 A1 + Vin

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 B1 +Vin

Course A2 + Vin

Course B2 +Vin

Course A3 + Vin

Course B3 +Vin

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

Maintenance therapy

Qing Yuan, MD

Yali Han, MD

Yali Han

Yijin Gao, MD

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.

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.

All enrolled patients stratified into high risk group are assigned to one treatment regimen

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

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

Study protocol, SAP and ICF were shared before study initiation. Patient data and the information about the process of the study will be shared within the all participants annually after enrollment patients.

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL	NCT04881838	Pediatric Anapl...	P regimen Course A1 + Vin Course B1 +Vin Course A2 + Vin Course B2 +Vin Course A3 + Vin Course B3 +Vin Maintenance the...	- 18 Years	Children's Cancer Group, China
CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL	NCT04881838	Pediatric Anapl...	P regimen Course A1 + Vin Course B1 +Vin Course A2 + Vin Course B2 +Vin Course A3 + Vin Course B3 +Vin Maintenance the...	- 18 Years	Children's Cancer Group, China

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