Prospective study of preventive Foscarnet sodium administration to confirm the safety and preventive effect of HHV-6 encephalitis after hematopoietic stem cell transplantation

UMIN ID: UMIN000001706

Registered date:13/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hematologic disorder, who receive hematopoietic stem cell transplantation (HSCT) from alternative donor
• Date of first enrollment: 2009/02/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): We administer PFA 90mg/kg/day from day +7 to day +21 in bone marrow transplant/peripheral blood stem cell transplant receipient and to day +25 in cord blood transplant receipient. During the PFA adminstration, we measure the amount of plasma HHV-6 triweekly. In case the amount of HHV-6 DNA excess 1x10e4 copy/ml, we increase PFA doses for 180mg/kg/day.

Outcome(s)

• Primary Outcome: Safety of PFA administration at early post-HSCT period

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.