Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045292
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2002-09-06
Brief Title:
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Multicenter Study of Cytomegalovirus Prophylaxis With Valacyclovir for the Prevention of Serious Fungal and Bacterial Infections Among Cytomegalovirus Seronegative Recipients of Cytomegalovirus Seropositive Sx Stem Cell Transplants
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation
PURPOSE Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation
PURPOSE Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation
Detailed Description:
OBJECTIVES
Compare the occurrence of serious invasive fungal or bacterial infections during the first 270 days after transplantation in cytomegalovirus CMV-negative patients receiving a CMV-positive allogeneic stem cell transplantation and valacyclovir or placebo
Compare the occurrence of primary CMV infection within the first 100 days after transplantation in patients treated with these regimens
Compare the survival of these patients at 100 days and 270 days post-transplantation
Compare the occurrence of CMV disease at day 100 and day 270 post-transplantation in patients treated with these regimens
Compare the safety of these regimens in these patients
Correlate the presence of CMV in stem cell product with post-transplantation CMV infection in these patients
Determine if subclinical CMV infection results in a virus-specific immune response humoral and cellular in these patients
Compare the quality of life of patients treated with these regimens
Compare resource utilization eg rates of hospitalization number of days alive out of the hospital days in the intensive care unit days on mechanical ventilation use of antimicrobials and filgrastim G-CSF and number of invasive procedures in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and type of transplantation matched related vs mismatchedunrelated Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral valacyclovir 4 times daily beginning with transplantation conditioning usually day -5 and continuing until day 100 after transplantation Patients receive high-dose acyclovir instead of valacyclovir IV every 8 hours beginning on day -1 and continuing until oral medications are tolerated Allogeneic stem cells are infused on day 0
Arm II Patients receive oral or IV placebo on the same schedule as in arm I Quality of life is assessed at baseline and on days 50 and 100
Patients are followed every 2 weeks for 6 months
PROJECTED ACCRUAL A total of 115-230 patients 58-115 per treatment arm will be accrued for this study within 2 years
Compare the occurrence of serious invasive fungal or bacterial infections during the first 270 days after transplantation in cytomegalovirus CMV-negative patients receiving a CMV-positive allogeneic stem cell transplantation and valacyclovir or placebo
Compare the occurrence of primary CMV infection within the first 100 days after transplantation in patients treated with these regimens
Compare the survival of these patients at 100 days and 270 days post-transplantation
Compare the occurrence of CMV disease at day 100 and day 270 post-transplantation in patients treated with these regimens
Compare the safety of these regimens in these patients
Correlate the presence of CMV in stem cell product with post-transplantation CMV infection in these patients
Determine if subclinical CMV infection results in a virus-specific immune response humoral and cellular in these patients
Compare the quality of life of patients treated with these regimens
Compare resource utilization eg rates of hospitalization number of days alive out of the hospital days in the intensive care unit days on mechanical ventilation use of antimicrobials and filgrastim G-CSF and number of invasive procedures in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center and type of transplantation matched related vs mismatchedunrelated Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral valacyclovir 4 times daily beginning with transplantation conditioning usually day -5 and continuing until day 100 after transplantation Patients receive high-dose acyclovir instead of valacyclovir IV every 8 hours beginning on day -1 and continuing until oral medications are tolerated Allogeneic stem cells are infused on day 0
Arm II Patients receive oral or IV placebo on the same schedule as in arm I Quality of life is assessed at baseline and on days 50 and 100
Patients are followed every 2 weeks for 6 months
PROJECTED ACCRUAL A total of 115-230 patients 58-115 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000256871 | REGISTRY | PDQ | None |
| FHCRC-160300 | None | None | None |
| NCI-H02-0092 | None | None | None |