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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03971305
Other study ID # SCCCG-ALCL-2017-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 5, 2017
Est. completion date May 5, 2025

Study information

Verified date May 2022
Source Sun Yat-sen University
Contact Sun Xiao-Fei
Phone 13600099837
Email sunxf@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

Research purpose: 1. To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma. 2. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival. 3. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD. 4. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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

Outcome

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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