NCT03971305

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

May 30, 2019

Last Update Submit

May 5, 2022

Conditions

MRDMDDLymphoma, NonhodgkinAnaplastic LymphomaPediatric Cancer

Outcome Measures

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

    through study completion, maximal eight years

Secondary Outcomes (4)

  • Overall survival (OS)

    through study completion, maximal eight years

  • Relapse-free survival (RFS)

    through study completion, maximal eight years

  • Response rate (RR)

    on an average 3 weeks after finish of treatment

  • Adverse event rate

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

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age \< 18 years old
  • Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma
  • Newly diagnosed patients
  • Informed consent of guardian of children patients

You may not qualify if:

  • Secondary immunodeficiency disease
  • Second neoplasm
  • Primary cutaneous anaplastic large cell lymphoma
  • Recurrent and progressive patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 16173961RESULT

  • 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.

    PMID: 22084369RESULT

  • 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.

    PMID: 24297868RESULT

  • 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.

    PMID: 25116372RESULT

  • 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.

    PMID: 20679620RESULT

  • Chen 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.

    PMID: 38810968DERIVED

MeSH Terms

Conditions

Lymphoma, Non-HodgkinNeoplasms

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Sun Xiaofei

    Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

Sun Xiao-Fei

CONTACT

13600099837sunxf@sysucc.org.cn

Zhen Zi-Jun

CONTACT

13609712260zhenzj@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

May 5, 2017

Primary Completion

May 5, 2022

Study Completion

May 5, 2025

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)