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

Sun Yat-sen University200 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Childhood Non-Hodgkin's Lymphoma

Interventions

Modified BFM-90 protocolOTHER

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 5 years

Secondary Outcomes

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.

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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