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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761500
First Posted: January 4, 2013
Last Update Posted: January 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xiao-Fei Sun, Sun Yat-sen University
  Purpose
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 Intervention Phase
Childhood Non-Hodgkin's Lymphoma Other: Modified BFM-90 protocol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Xiao-Fei Sun, Sun Yat-sen University:

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.


Enrollment: 200
Study Start Date: March 1998
Study Completion Date: December 2011
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Xiao-Fei Sun, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01761500     History of Changes
Other Study ID Numbers: Ped-No-1
First Submitted: December 21, 2012
First Posted: January 4, 2013
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Xiao-Fei Sun, Sun Yat-sen University:
Non-Hodgkin's lymphoma;
Childhood and adolescence;
Survival Rate

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases