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Phase 2
6 Months
20 Years
Not Enrolling
Both
Childhood Non-Hodgkin's Lymphoma

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Trial Information


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The event free survival (EFS)

Outcome 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.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

Ped-No-1

NCT ID:

NCT01761500

Start Date:

March 1998

Completion Date:

December 2011

Related Keywords:

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

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