A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- 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
- 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
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Late cytomegalovirus infection by plasma PCR positivity
Michael Boeckh, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|