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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01761500

Enrollment

200

Registered

2013-01-04

Start date

1998-03-31

Completion date

2011-12-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Non-Hodgkin's Lymphoma

Keywords

Non-Hodgkin's lymphoma;, Childhood and adolescence;, Survival Rate

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.

Interventions

OTHERModified BFM-90 protocol

Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 20 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The event free survival (EFS)	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

Measure	Time frame	Description
Number of Participants with Adverse Events	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

Measure	Time frame	Description
the characteristics of Chinese children and adolescents with NHL	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026