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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03971318
Other study ID # SCCCG-LBL-2017-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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