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RecruitingNCT03971305Updated May 9, 2022

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

An observational study in MRD, MDD and Lymphoma, Nonhodgkin, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Primary completion was expected by May 2022, 4 years 5 months ago, but the record still lists the study as recruiting.
  • Started May 2017; still recruiting 9 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the detailed 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.
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Conditions studied

  • MRD
  • MDD
  • Lymphoma, Nonhodgkin
  • Anaplastic Lymphoma
  • Pediatric Cancer
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 300 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Systemic ALK-positive anaplastic large cell lymphoma patients # age at diagnosis \< 18 years.

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

Exclusion Criteria:

  1. Secondary immunodeficiency disease
  2. Second neoplasm
  3. Primary cutaneous anaplastic large cell lymphoma
  4. Recurrent and progressive patients.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, maximal eight years

Secondary outcomes

  1. Overall survival (OS)

    OS is defined as time from start of treatment/randomization up to death of any

    Time frame: through study completion, maximal eight years

  2. 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.

    Time frame: through study completion, maximal eight years

  3. Response rate (RR)

    Complete response, partial remission, objective effect, stable disease or progressive disease

    Time frame: on an average 3 weeks after finish of treatment

  4. Adverse event rate

    Rate of patients with acute toxicity defined as grade III/IV/V AE

    Time frame: from the first day of protocol defined treatment until two years after start of protocol defined treatment

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Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Publications

  • 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 Haematol. 2005 Oct;131(1):39-49. doi: 10.1111/j.1365-2141.2005.05735.x. PubMed 16173961 ↗
  • Lamant 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. PubMed 22084369 ↗
  • 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 lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2. PubMed 24297868 ↗
  • 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: 10.3109/08880018.2014.939793. Epub 2014 Aug 12. PubMed 25116372 ↗
  • 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, 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. PubMed 20679620 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03971305
Lead sponsor
Sun Yat-sen University
Responsible party
Xiao-Fei Sun (professor, Sun Yat-sen University) — Principal investigator
First posted
Jun 3, 2019
Start date
May 5, 2017
Primary completion
May 5, 2022 (estimated)
Completion
May 5, 2025 (estimated)
Last update
May 9, 2022

Study contacts

Sun Xiao-Fei
Contact
sunxf@sysucc.org.cn
13600099837 ext. +86
Zhen Zi-Jun
Contact
zhenzj@sysucc.org.cn
13609712260 ext. +86
Sun Xiaofei
study director · Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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