Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075803
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2004-01-09
Brief Title:
Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants BMT CTN 0101
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Randomized Double-blind Trial of Fluconazole Versus Voriconazole for the Prevention of Invasive Fungal Infections in Allogeneic Blood and Marrow Transplant Patients BMT CTN 0101
Status:
COMPLETED
Status Verified Date:
2022-12
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:
The study is designed as a Phase III randomized double-blind multicenter prospective comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients Recipients will be stratified by center and donor type sibling vs unrelated and will be randomized to either the fluconazole or voriconazole arm in a 11 ratio
Detailed Description:
BACKGROUND
Allogeneic blood and marrow transplant patients are highly susceptible to invasive fungal infection prior to engraftment due to neutropenia and mucosal injury After engraftment an impairment of cell mediated immunity from graft-versus-host disease GVHD and the use of aggressive immunosuppressive therapies such as corticosteroids leave patients vulnerable to invasive fungal infections Recipients of alternate donor transplants are especially susceptible due to slow reconstitution of cell mediated immunity
Fluconazole prophylaxis in prospective randomized trials of both autologous and allogeneic transplant recipients has been demonstrated to reduce invasive fungal infections due to yeasts prior to engraftment A prolonged course of fluconazole given during the first 75 days to cover the early post-engraftment period of risk is highly effective in the prevention of early and later yeast infections This has translated into a survival benefit A recent analysis of long-term outcomes of these individuals demonstrated a continuing benefit beyond the course of prophylaxis with a further benefit in survival In another study of various factors associated with survival after matched unrelated donor transplants fluconazole prophylaxis was an independent predictor for overall survival in a multivariate analysis Fluconazole prophylaxis has been found to be effective and safe with few substantive drug interactions and has been widely adopted by transplant clinicians
DESIGN NARRATIVE
This is a randomized double-blind multicenter prospective comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic hematopoietic transplant recipients and cord blood recipients in children under the age of 12 Prior to the start of the pre-transplant conditioning regimen participants will give written informed consent and be screened for eligibility Participants who meet all entry criteria will be assigned randomly to voriconazole or fluconazole within 72 hours of Day 0 Participants will begin the study drug on Day 0 after completion of the conditioning regimen Day 0 is defined as the day infusion of the stem cell product is completed The study drug will be continued until Day 100 following transplant or until one or more criteria for early withdrawal are met Continuation of the study drug beyond Day 100 is permitted for participants who meet specific criteria The development of any fungal infection during prophylaxis will be classified according to the definitions listed in the protocol
Allogeneic blood and marrow transplant patients are highly susceptible to invasive fungal infection prior to engraftment due to neutropenia and mucosal injury After engraftment an impairment of cell mediated immunity from graft-versus-host disease GVHD and the use of aggressive immunosuppressive therapies such as corticosteroids leave patients vulnerable to invasive fungal infections Recipients of alternate donor transplants are especially susceptible due to slow reconstitution of cell mediated immunity
Fluconazole prophylaxis in prospective randomized trials of both autologous and allogeneic transplant recipients has been demonstrated to reduce invasive fungal infections due to yeasts prior to engraftment A prolonged course of fluconazole given during the first 75 days to cover the early post-engraftment period of risk is highly effective in the prevention of early and later yeast infections This has translated into a survival benefit A recent analysis of long-term outcomes of these individuals demonstrated a continuing benefit beyond the course of prophylaxis with a further benefit in survival In another study of various factors associated with survival after matched unrelated donor transplants fluconazole prophylaxis was an independent predictor for overall survival in a multivariate analysis Fluconazole prophylaxis has been found to be effective and safe with few substantive drug interactions and has been widely adopted by transplant clinicians
DESIGN NARRATIVE
This is a randomized double-blind multicenter prospective comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic hematopoietic transplant recipients and cord blood recipients in children under the age of 12 Prior to the start of the pre-transplant conditioning regimen participants will give written informed consent and be screened for eligibility Participants who meet all entry criteria will be assigned randomly to voriconazole or fluconazole within 72 hours of Day 0 Participants will begin the study drug on Day 0 after completion of the conditioning regimen Day 0 is defined as the day infusion of the stem cell product is completed The study drug will be continued until Day 100 following transplant or until one or more criteria for early withdrawal are met Continuation of the study drug beyond Day 100 is permitted for participants who meet specific criteria The development of any fungal infection during prophylaxis will be classified according to the definitions listed in the protocol
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 |
|---|---|---|---|
| BMT CTN 0101 | OTHER | None | None |
| U01HL069294 | NIH | None | None |
| 5U24CA076518 | NIH | Blood and Marrow Transplant Clinical Trial Network | httpsreporternihgovquickSearch5U24CA076518 |