Randomized Trial Of Safety And Tolerability Of Intravenous/Oral Voriconazole Versus Intravenous/Oral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients
OBJECTIVES:
- Compare the safety and tolerability of voriconazole vs itraconazole for the prevention
of fungal infections in patients undergoing allogeneic hematopoietic stem cell
transplantation.
OUTLINE: This is a randomized study. Patients are stratified according to donor type
(related vs unrelated). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning after allogeneic hematopoietic stem cell transplantation (AHSCT),
patients receive voriconazole IV twice daily on days 1-14 and then orally* twice daily
on days 15-100.
- Arm II: Beginning after AHSCT, patients receive itraconazole IV twice daily on days
1-2, once daily on days 3-14, and then orally* twice daily on days 15-100.
NOTE: *Patients unable to tolerate oral medication may continue IV medication beyond day 14.
In both arms, treatment continues in the absence of unacceptable toxicity or an invasive
fungal infection. Patients requiring corticosteroid therapy for graft-versus-host disease
continue to receive voriconazole or itraconazole beyond day 100.
Patients are followed until day 180 post-transplantation.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Mary C. Territo, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
CDR0000355116
NCT00079222
November 2003
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
