A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With LBL

NCT ID: NCT03971318

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. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. 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. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..

Detailed Description

Research purpose:

1. To investigate the efficacy and safety of SCCCG-LBL-2017 in Chinese children with LBL.

2. To explore the feasibility of risk stratification of T-LBL by combining genotyping.

3. To investigate the correlation between MDD and MRD in lymphoblastic lymphoma and prognosis.

4. To investigate the role of PET/CT in the assessment of residual lymphoblastic lymphoma.

5. To explore the effect of reducing HD-MTX dosage and shortening maintenance therapy time on the efficacy and survival of low-risk LBL patients.

6. To explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk LBL patients.

Conditions

Lymphoma, Non-Hodgkin; Lymphoblastic Lymphoma, Childhood; PTEN Loss; NOTCH1 Gene Mutation; Pediatric Cancer

Study Design

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

Eligibility Criteria

Inclusion Criteria

1. Age < 18 years old

2. Pathologically confirmed lymphoblastic lymphoma

3. Newly diagnosed patients

4. Informed consent of guardian of children patients -

Exclusion Criteria

1. Age > 18 years old

2. Recurrent lymphoblastic lymphoma

3. Secondary immunodeficiency.

• 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

Zhen zijun

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhen zijun

Role: CONTACT

zhenzj@sysucc.org.cn

13609712260 ext. +86

Sun xiaofei

Role: CONTACT

sunxf@sysucc.org.cn

13600099837 ext. +86

Facility Contacts

Zhen zijun

Role: primary

zhenzj@sysucc.org.cn

13609712260 ext. +86

Sun xiaofei

Role: backup

sunxf@sysucc.org.cn

13600099837 ext. +86

References

Bonn BR, Rohde M, Zimmermann M, Krieger D, Oschlies I, Niggli F, Wrobel G, Attarbaschi A, Escherich G, Klapper W, Reiter A, Burkhardt B. Incidence and prognostic relevance of genetic variations in T-cell lymphoblastic lymphoma in childhood and adolescence. Blood. 2013 Apr 18;121(16):3153-60. doi: 10.1182/blood-2012-12-474148. Epub 2013 Feb 8.

Reference Type: BACKGROUND

PMID: 23396305 (View on PubMed)

Callens C, Baleydier F, Lengline E, Ben Abdelali R, Petit A, Villarese P, Cieslak A, Minard-Colin V, Rullier A, Moreau A, Baruchel A, Schmitt C, Asnafi V, Bertrand Y, Macintyre E. Clinical impact of NOTCH1 and/or FBXW7 mutations, FLASH deletion, and TCR status in pediatric T-cell lymphoblastic lymphoma. J Clin Oncol. 2012 Jun 1;30(16):1966-73. doi: 10.1200/JCO.2011.39.7661. Epub 2012 Apr 30.

Reference Type: RESULT

PMID: 22547598 (View on PubMed)

Other Identifiers

SCCCG-LBL-2017-001

Identifier Type: -

Identifier Source: org_study_id