A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 184
- Locations
- 7
- Primary Endpoint
- Late cytomegalovirus infection by plasma PCR positivity
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Supportive Care
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Late cytomegalovirus infection by plasma PCR positivity
Secondary Outcomes
No secondary outcomes reported