Voriconazole Compared With Itraconazole in Preventing Fun... | NCT00079222 | Trialant
NCT00079222
Sponsor
Jonsson Comprehensive Cancer Center
Status
Completed
Last Update Posted
Aug 3, 2020Actual
Enrollment
Not provided
Phase
Not Applicable
Conditions
Cancer
Interventions
itraconazole
voriconazole
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00079222
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000355116
Secondary IDs
ID
Type
Description
Link
UCLA-0307071
Brief Title
Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Official Title
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
Acronym
Not provided
Organization
Jonsson Comprehensive Cancer CenterOTHER
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2003
Primary Completion Date
Apr 2005Actual
Completion Date
Not provided
First Submitted Date
Mar 8, 2004
First Submission Date that Met QC Criteria
Mar 9, 2004
First Posted Date
Mar 10, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 30, 2020
Last Update Posted Date
Aug 3, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Jonsson Comprehensive Cancer CenterOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.
PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.
Detailed Description
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.
Conditions Module
Conditions
Cancer
Keywords
infection
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute lymphoblastic leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies