Back to resultsImprove the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
Primary Purpose
Childhood Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Modified BFM-90 protocol
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Non-Hodgkin's Lymphoma focused on measuring Non-Hodgkin's lymphoma;, Childhood and adolescence;, Survival Rate
Eligibility Criteria
Inclusion Criteria:
- Untreated children and adolescents with Non-Hodgkin's lymphoma
- Age ≤ 20 years
- The informed consent of their guardians was obtained.
Exclusion Criteria:
- Recurrence Non-Hodgkin's lymphoma
- Age >20 years
- No abide by the protocol
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Modified BFM-90 protocol
Arm Description
Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL
Outcomes
Primary Outcome Measures
The event free survival (EFS)
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
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.
Full Information
NCT ID
NCT01761500
First Posted
December 21, 2012
Last Updated
January 3, 2013
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01761500
Brief Title
Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Non-Hodgkin's Lymphoma
Keywords
Non-Hodgkin's lymphoma;, Childhood and adolescence;, Survival Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified BFM-90 protocol
Arm Type
Other
Arm Description
Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL
Intervention Type
Other
Intervention Name(s)
Modified BFM-90 protocol
Intervention Description
Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL
Primary Outcome Measure Information:
Title
The event free survival (EFS)
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
the characteristics of Chinese children and adolescents with NHL
Description
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.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Untreated children and adolescents with Non-Hodgkin's lymphoma
Age ≤ 20 years
The informed consent of their guardians was obtained.
Exclusion Criteria:
Recurrence Non-Hodgkin's lymphoma
Age >20 years
No abide by the protocol
12. IPD Sharing Statement
Learn more about this trial
Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
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