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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT01761500
Collaborator
(none)
200
Enrollment
1
Arm
165
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Modified BFM-90 protocol
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 1998
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Other Outcome Measures

  1. the characteristics of Chinese children and adolescents with NHL [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiao-Fei Sun, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01761500
Other Study ID Numbers:
  • Ped-No-1
First Posted:
Jan 4, 2013
Last Update Posted:
Jan 4, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Xiao-Fei Sun, Professor, Sun Yat-sen University
Non-Hodgkin's lymphoma;
Childhood and adolescence;
Survival Rate
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Jan 4, 2013