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

NCT ID: NCT03971305

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2025-05-05

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.

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.

Conditions

MRD; MDD; Lymphoma, Nonhodgkin; Anaplastic Lymphoma; Pediatric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Fei Sun

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sun Xiaofei

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sun Xiao-Fei

Role: CONTACT

sunxf@sysucc.org.cn

13600099837 ext. +86

Zhen Zi-Jun

Role: CONTACT

zhenzj@sysucc.org.cn

13609712260 ext. +86

Facility Contacts

Sun Xiaofei

Role: primary

sunxf@sysucc.org.cn

13600099837 ext. +86

References

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.

Reference Type: RESULT

PMID: 16173961 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22084369 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24297868 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25116372 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20679620 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38810968 (View on PubMed)

Other Identifiers

SCCCG-ALCL-2017-001

Identifier Type: -

Identifier Source: org_study_id