Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
|ClinicalTrials.gov Identifier: NCT00016068|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 17, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Infection||Drug: ganciclovir Drug: valganciclovir||Phase 3|
- Compare cytomegalovirus (CMV) disease and non-CMV invasive infection-free survival in patients undergoing allogeneic hematopoietic stem cell transplantation treated with valganciclovir vs placebo.
- Compare the incidence of CMV disease in patients treated with these drugs.
- Compare the incidence of other severe invasive bacterial and fungal infections and overall survival in patients treated with these drugs.
- Compare the incidence of CMV infection or disease at baseline and at days 270 and 640 after allogeneic hematopoietic stem cell transplantation in patients treated with these drugs.
- Compare the incidence of herpes simplex virus and varicella-zoster virus infections at baseline and day 270 in patients treated with these drugs.
- Determine the safety of valganciclovir in these patients.
- Compare the quality of life of patients treated with these drugs.
- Compare CMV-specific immune reconstitution in patients treated with these drugs.
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.
- Arm I: Patients receive oral valganciclovir daily.
- Arm II: Patients receive oral placebo daily. Treatment begins around day 80-120 post-transplantation and continues until day 270 post-transplantation in the absence of active infection or unacceptable toxicity. Patients developing active cytomegalovirus (CMV) infection receive induction doses of ganciclovir IV or open-label oral valganciclovir for 1 week followed by open-label oral valganciclovir maintenance dosing until CMV can no longer be detected.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation|
|Study Start Date :||January 2001|
|Actual Study Completion Date :||September 2007|
U.S. FDA Resources
- Late cytomegalovirus infection by plasma PCR positivity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016068
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610-0232|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Michael Boeckh, MD||Fred Hutchinson Cancer Research Center|