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

January 3, 2013 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ped-No-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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