Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT01761500|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sun Yat-sen University
Information provided by (Responsible Party):
Xiao-Fei Sun, Sun Yat-sen University
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.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Non-Hodgkin's Lymphoma||Other: Modified BFM-90 protocol||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||December 2011|
Modified BFM-90 protocol
Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL
Other: Modified BFM-90 protocol
Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL
Primary Outcome Measures :
- The event free survival (EFS) [ Time Frame: 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 :
- Number of Participants with Adverse Events [ Time Frame: 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.
Other Outcome Measures:
- the characteristics of Chinese children and adolescents with NHL [ Time Frame: Up to 5 years ]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.
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