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

NCT ID: NCT01761500

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31
• Study Completion Date: 2011-12-31

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.

Conditions

Childhood Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified BFM-90 protocol

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

Group Type: OTHER

Modified BFM-90 protocol

Intervention Type: OTHER

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

Interventions

Modified BFM-90 protocol

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Fei Sun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Ped-No-1

Identifier Type: -

Identifier Source: org_study_id