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

randomized trial for the efficacy of primary prophylaxis with granulocyte colony stimulating factor in advanced childhood mature B-cell malignancies - B-NHL03 G-CSF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000675
Enrollment
90
Registered
2007-04-11
Start date
2004-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

advanced childhood mature B-cell malignancies

Interventions

granulocyte colony stimulating factor no granulocyte colony stimulating factor

Sponsors

Japan Pediatric Leukemia/Lymphoma Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: regiatered cases in Group3,4 of JPLSG multicenter trial for childhood mature B-cell malignancies informed consent from the patients' guardians

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence of febrile neutropenia—

Secondary

MeasureTime frame
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—

Countries

Japan

Contacts

Public ContactAkira Kikuchi

Teikyo University School of Medicine Department of Pediatrics

akikuchi-tky@umin.ac.jp03-3964-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026