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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Prospective Multicenter Cohort Study on the Efficacy and Safety of Stratified Treatment of Chinese Children With Lymphoblastic Lymphoma Based on Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03971318
• Other study ID #: SCCCG-LBL-2017-001
• Status: Recruiting
• Start date: May 5, 2017
• Est. completion date: May 5, 2025

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Zhen zijun
• Phone: 13609712260
• Email: zhenzj[@]sysucc.org.cn
• Is FDA regulated: No
• 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. 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..

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.

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 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.

Related Conditions & MeSH terms

• Lymphoblastic Lymphoma, Childhood
• Lymphoma
• Lymphoma, Non-Hodgkin
• NOTCH1 Gene Mutation
• Pediatric Cancer
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• PTEN Loss

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 (2)

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. — View Citation

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 s — 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	through study completion, maximal eight years