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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Childhood Non-Hodgkin's Lymphoma

Treatments: Other: Modified BFM-90 protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01761500

Ped-No-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 6 months to 20 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Modified BFM-90 protocol

Other group

Description:

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

Treatment:

Other: Modified BFM-90 protocol