Pediatric Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | May 5, 2025 |
Est. primary completion date | May 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: 1. Age < 18 years old 2. Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma 3. Newly diagnosed patients 4. Informed consent of guardian of children patients Exclusion Criteria: 1. Secondary immunodeficiency disease 2. Second neoplasm 3. Primary cutaneous anaplastic large cell lymphoma 4. Recurrent and progressive patients. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Burkhardt B, Zimmermann M, Oschlies I, Niggli F, Mann G, Parwaresch R, Riehm H, Schrappe M, Reiter A; BFM Group. The impact of age and gender on biology, clinical features and treatment outcome of non-Hodgkin lymphoma in childhood and adolescence. Br J Ha — View Citation
Damm-Welk C, Mussolin L, Zimmermann M, Pillon M, Klapper W, Oschlies I, d'Amore ES, Reiter A, Woessmann W, Rosolen A. Early assessment of minimal residual disease identifies patients at very high relapse risk in NPM-ALK-positive anaplastic large-cell lymp — View Citation
Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugières L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-c — View Citation
Le Deley MC, Rosolen A, Williams DM, Horibe K, Wrobel G, Attarbaschi A, Zsiros J, Uyttebroeck A, Marky IM, Lamant L, Woessmann W, Pillon M, Hobson R, Mauguen A, Reiter A, Brugières L. Vinblastine in children and adolescents with high-risk anaplastic large — View Citation
Sun X, Zhen Z, Lin S, Zhu J, Wang J, Lu S, Chen Y, Zhang F, Sun F, Li P. Treatment outcome of Chinese children with anaplastic large cell lymphoma by using a modified B-NHL-BFM-90 protocol. Pediatr Hematol Oncol. 2014 Sep;31(6):518-27. doi: 10.3109/088800 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall survival (OS) | OS is defined as time from start of treatment/randomization up to death of any | through study completion, maximal eight years | |
Secondary | 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 | |
Secondary | Response rate (RR) | Complete response, partial remission, objective effect, stable disease or progressive disease | on an average 3 weeks after finish of treatment | |
Secondary | 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 |
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