- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761500
Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
January 3, 2013 updated by: Xiao-Fei Sun, Sun Yat-sen University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Modified BFM-90 protocol
Using the Modified BFM-90 protocol to treat Chinese children and adolescents with NHL
|
Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1998
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 21, 2012
First Submitted That Met QC Criteria
January 3, 2013
First Posted (Estimate)
January 4, 2013
Study Record Updates
Last Update Posted (Estimate)
January 4, 2013
Last Update Submitted That Met QC Criteria
January 3, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ped-No-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Modified BFM-90 protocol
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Sun Yat-sen UniversityRecruitingNon-hodgkin LymphomaChina
-
Israeli Medical AssociationRecruitingHigh-Risk Cancer | Philadelphia-Negative ALLIsrael
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Boston University Charles River CampusUniversity of Kentucky; Harvard School of Public Health (HSPH)RecruitingDepressive Disorder | Anxiety DisordersUnited States
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Imam Abdulrahman Bin Faisal UniversityActive, not recruitingBirth Weight | Preterm | Feeding Disorder NeonatalSaudi Arabia
-
Tuğba AtanCompletedCoronary Artery DiseaseTurkey
-
University of Sao PauloCompletedContracture of Elbow JointBrazil
-
Clalit Health ServicesCompleted
-
University of AlcalaCompletedVascular Diseases | Lipedema | Dermatologic Complication | AssessmentSpain
-
Universidade Cidade de Sao PauloTerminatedPatellar TendinopathyBrazil
-
University Medical Centre LjubljanaActive, not recruitingPulmonary Vein IsolationSlovenia