randomized trial for the efficacy of primary prophylaxis with granulocyte colony stimulating factor in advanced childhood mature B-cell malignancies

UMIN ID: UMIN000000675

Registered date:11/04/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: advanced childhood mature B-cell malignancies
• Date of first enrollment: 2004/11/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

granulocyte colony stimulating factor
no granulocyte colony stimulating factor

Outcome(s)

• Primary Outcome: Incidence of febrile neutropenia
• Secondary Outcome: Incidence of severe infection duration of neutropenia febrile period treatment period Incidence of Grade 3,4 adverse event in stomatitis,thrombocytopenia,interstitial pneumonitis,acute respiratory distress syndrome, myalgia and bone pain transfusion number of red blood cell and platelet remission induction rate event free survival at 1 year and 2 years total medical costs in treatment period

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude criteria: severe dysfunction in liver, kidney, heart and lung uncontrolable complications such as severe infection, diabetes mellitua or myocardial infarction hypersensitivity for lenograstim or other G-CSF products

Related Information

• Primary Sponsor: Japan Pediatric Leukemia/Lymphoma Study Group
• Source(s) of Monetary Support: Japan Pediatric Leukemia/Lymphoma Study Group