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

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ClinicalTrials.gov Identifier: NCT01761500
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Xiao-Fei Sun, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE December 21, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE March 1998
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 3, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Childhood Non-Hodgkin's Lymphoma
Intervention  ICMJE Other: Modified BFM-90 protocol
Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL
Study Arms  ICMJE Modified BFM-90 protocol
Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL
Intervention: Other: Modified BFM-90 protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761500
Other Study ID Numbers  ICMJE Ped-No-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiao-Fei Sun, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP