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

Phase 2

Completed

• Conditions: Childhood Non-Hodgkin's Lymphoma
• Interventions: Other: Modified BFM-90 protocol

• Registration Number: NCT01761500
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1998-03
• Primary Completion: 2008-01
• Study Completion: 2011-12
• Study First Submitted: 2012-12-21
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified BFM-90 protocol	Modified BFM-90 protocol	Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL

Primary Outcome Measures

Name	Time	Method
The event free survival (EFS)	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to 5 years	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.