Prospective study of Foscarnet sodium administration for the prevention of HHV-6 encephalitis after hematopoietic stem cell transplantation

UMIN ID: UMIN000001346

Registered date:30/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with hematologic malignancies, transplanted unrelated cord blood (UCBT) or HLA-one haplotype mismatch graft from a relative (haplo SCT)
• Date of first enrollment: 2007/09/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): We measure the amount of HHV-6 DNA in plasma triweekly. When the amount of HHV-6 DNA excess 5x10e2 copy/ml, we start PFA administration 90mg/kg/day and continue the measurement triweekly. In case the amount of HHV-6 DNA excess 1x10e5 copy/ml, we increase PFA doses for 180mg/kg/day, and in case HHV-6 DNA become negative, stop PFA administration.

Outcome(s)

• Primary Outcome: Frequency of adverse event caused by PFA administration by day 35 after SCT.
• Secondary Outcome: 1. Change of plasma HHV-6 DNA after PFA administration by day 35 after SCT. 2. Preventive effect of PFA administration by day 35 after SCT.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Hypersensitive for PFA 2. Existence of comorbid disease, grade 3 or more in CTCAE v3.0 (except renal insufficiency) 3. Existence of renal insufficiency, grade 2 or more in CTCAE v3.0 4. Unsuitable for enrollment judged by attending physian

Related Information

• Primary Sponsor: Cellular transplantation biology, Graduate School of Medical Science, Kanazawa University
• Source(s) of Monetary Support: Study group 'Morishima-han' to establish allo-SCT for refractory hematologic malignancies in adults, Ministry of Health, Labour and welfare.