A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL

Study Overview
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Brief Summary
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With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen，etc.

Detailed Description
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Research purpose: To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.

Official Title
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A Prospective Multicenters Clinical Cohort Study of the Efficacy and Safety of Stratified Risk Factors for Treatment of Chinese Children With Systemic ALK-positive Anaplastic Large Cell Lymphoma

Conditions
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MRD, MDD, Lymphoma, Nonhodgkin, Anaplastic Lymphoma, Pediatric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 18 years old Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma Newly diagnosed patients Informed consent of guardian of children patients Exclusion Criteria: Secondary immunodeficiency disease Second neoplasm Primary cutaneous anaplastic large cell lymphoma Recurrent and progressive patients.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival (EFS) | EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies | through study completion, maximal eight years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as time from start of treatment/randomization up to death of any | through study completion, maximal eight years | 
| Relapse-free survival (RFS) | RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse. | through study completion, maximal eight years | 
| Response rate (RR) | Complete response, partial remission, objective effect, stable disease or progressive disease | on an average 3 weeks after finish of treatment | 
| Adverse event rate | Rate of patients with acute toxicity defined as grade III/IV/V AE | from the first day of protocol defined treatment until two years after start of protocol defined treatment |