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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiao-Fei Sun, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01761500
First received: December 21, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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

Primary Outcome Measures:
  • The event free survival (EFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Xiao-Fei Sun, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01761500     History of Changes
Other Study ID Numbers: Ped-No-1
Study First Received: December 21, 2012
Last Updated: January 3, 2013
Health Authority: China: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013