A Phase 3 interventional study of ganciclovir and valganciclovir in Infection, sponsored by Fred Hutchinson Cancer Center. Completed at 7 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2010-05-17.
Sponsored by Fred Hutchinson Cancer Center · Phase 3, Interventional, and Supportive care
RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus.
PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, prior neutropenia (yes vs no), and presence of refractory graft-versus-host disease requiring secondary therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and days 180 and 270 post-transplantation.
Patients are followed at days 400, 520, and 640 post-transplantation.
PROJECTED ACCRUAL: A total of 184 patients (92 per treatment arm) will be accrued for this study.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 184 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor
Seropositive recipients with one of the following:
CMV infection before day 80, as determined by:
Presence of graft-versus-host disease (GVHD) at enrollment
No leukemic relapse
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent prophylactic high-dose acyclovir (more than 800 mg twice daily), valacyclovir (more than 500 mg twice daily), cidofovir (more than 0.5 mg/kg per week), or famciclovir (more than 500 mg/day) except for limited treatment courses at higher doses for varicella-zoster virus infections
Late cytomegalovirus infection by plasma PCR positivity
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center