Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma

Childhood Non-Hodgkin's Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761500
• Other study ID #: Ped-No-1
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2012
• Last updated: January 3, 2013
• Start date: March 1998
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol in Chinese children and adolescents with Non-Hodgkin's lymphoma.

Description:

Non-Hodgkin's Lymphoma (NHL) in children and adolescents include Burkitt's lymphoma (BL), diffuse large B cell lymphoma (DLBL), anaplastic large cell lymphoma (ALCL) and lymphoblastic lymphoma (LBL). These subtypes of NHL are an aggressive group of diseases. At present, in developed countries, 80 to 90% of children with NHL are cured by intensive, risk-adapted chemotherapy.The best protocols include BFM-90, LMB-89 and FAB/LMB/96. However, in developing countries, such as those with low and moderate incomes, the limited availability of resources is an obstacle for using these complicated and intensive protocols.As such, very simple protocols, such as the CHOP protocol, were often used to treat children and adolescents with NHL, thus resulting in poor survival rates. To improve the survival rate of Chinese children and adolescents with NHL, This study was designed to evaluate the efficacy and toxicity of this modified NHL-BFM -90 protocol in Chinese children and adolescents with NHL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 20 Years

Eligibility

Inclusion Criteria:

1. Untreated children and adolescents with Non-Hodgkin's lymphoma

2. Age = 20 years

3. The informed consent of their guardians was obtained.

Exclusion Criteria:

1. Recurrence Non-Hodgkin's lymphoma

2. Age >20 years

3. No abide by the protocol

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Non-Hodgkin's Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Other:
• Modified BFM-90 protocol
Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the characteristics of Chinese children and adolescents with NHL	To assess and compare the characteristics of Chinese children and adolescents with NHL with that in western countries,such as sex, age, pathological subtypes,tumor involvement location and treatment outcome,and so on.	Up to 5 years	No
Primary	The event free survival (EFS)	The event free survival (EFS) was defined as the time from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, or to the date of the last follow up if patient did not experience any event.	Up to 5 years	No
Secondary	Number of Participants with Adverse Events	To assess the number of adverse events from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, severe infection, therapy related complication and second malignancy.	Up to 5 years	Yes