Clinical trial · Observational
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Lymphoma | Anaplastic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Nonhodgkin | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| MDD | — | UNRESOLVED | — |
| MRD | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival (EFS)
- timeFrame
- through study completion, maximal eight years
- description
- 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
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- through study completion, maximal eight years
- description
- OS is defined as time from start of treatment/randomization up to death of any
- measure
- Relapse-free survival (RFS)
- timeFrame
- through study completion, maximal eight years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- RESULTBurkhardt 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 Haematol. 2005 Oct;131(1):39-49. doi: 10.1111/j.1365-2141.2005.05735.x. PMID 16173961
- RESULTLamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugieres L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14. PMID 22084369
- RESULTDamm-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 lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2. PMID 24297868
- RESULTSun 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: 10.3109/08880018.2014.939793. Epub 2014 Aug 12. PMID 25116372
- RESULTLe 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, Brugieres L. Vinblastine in children and adolescents with high-risk anaplastic large-cell lymphoma: results of the randomized ALCL99-vinblastine trial. J Clin Oncol. 2010 Sep 1;28(25):3987-93. doi: 10.1200/JCO.2010.28.5999. Epub 2010 Aug 2. PMID 20679620
- DERIVEDChen T, Zeng C, Wang J, Sun F, Huang J, Zhu J, Lu S, Liao N, Zhang X, Chen Z, Yuan X, Yang Z, Guo H, Yang L, Wen C, Zhang W, Li Y, Luo X, Wu Z, Yang L, Liu R, Zheng M, He X, Sun X, Zhen Z. Stratified Treatment in Pediatric Anaplastic Large Cell Lymphoma: Result of a Prospective Open-Label Multiple-Institution Study. Cancer Res Treat. 2024 Oct;56(4):1252-1261. doi: 10.4143/crt.2024.104. Epub 2024 May 28.