Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016068
Status:
COMPLETED
Last Update Posted:
2010-05-17
First Post:
2001-05-06
Brief Title:
Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Multicenter Study Of Valganciclovir For The Prevention Of Late Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-H01-0072 | None | None | None |
| FHCRC-157700 | None | None | None |
| MSKCC-01127 | None | None | None |