CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 600 enrolled
Drug / intervention
Fluconazole +1 moredrug
Likely dose
Fluconazole 200 mg orally once daily or intravenously once daily; Voriconazole 200 mg orally twice daily or intravenouslyAI-extracted
Key inclusion· 7
  • ✓Must receive allogeneic peripheral blood, bone marrow, or cord blood transplant from family, unrelated, or sibling donor
  • ✓Must have 5 or 6 of 6 HLA-matched donor (serologic or molecular level per donor type)
  • ✓Underlying disease: AML, ALL, AUL, acute biphenotypic leukemia in CR1/CR2, CML in chronic/accelerated phase, MDS subtypes, or lymphoma with chemosensitive disease (≥50% response) receiving related donor transplant
  • ✓Receiving myeloablative conditioning regimens
Key exclusion· 14
  • ✕Invasive yeast infection within 8 weeks prior to conditioning regimen initiation (superficial infection or colonization allowed)
  • ✕History of candidemia within 8 weeks requires negative blood culture within 14 days of conditioning (7 days recommended), no clinical signs, and may not require ongoing antifungal therapy
  • ✕Presumptive, proven, or probable aspergillus or other mold infection or deep mycoses (including hepatosplenic candidiasis) within 4 months prior to conditioning
  • ✕Uncontrolled viral or bacterial infection at time of study registration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00075803
NCT00075803Phase 3Completed
CompareCT.gov

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)

Medical College of Wisconsin·interventional·Posted Jan 13, 2004·Updated Jan 4, 2023

In Brief

A Phase 3 clinical trial evaluating Fluconazole and Voriconazole for Lymphoma and 2 related conditions. Completed, enrolled 600 participants across 33 sites.

Detailed 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 1:1 ratio.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Infection, Leukemia
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2004
Enrollment StartNov 1, 2003
Primary CompletionSep 1, 2006
Study CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.5 years ago

Interventions

Fluconazoledrug

Fluconazole will be administered orally once daily. Fluconazole capsules should be taken at least one hour before or one hour after a meal. If oral drug is not possible, it will be given intravenously once daily in a total volume of 200 mL in patients \> 12 years. For adults, each 200 mL infusion will be administered over 2 hours. In patients \< 12 years, intravenous doses will be prepared.

Voriconazoledrug

Voriconazole will be administered orally twice daily. Voriconazole capsules should be taken at least one hour before or one hour after a meal. Taken concomitantly with food, bioavailability of voriconazole is reduced. If oral drug is not possible, it will be given intravenously at a dosage of 200 mg every 12 hours over two hours in patients \> 12 years. Each voriconazole dose will be diluted to a total volume of 200 mL in patients \> 12 years. Volumes of the formulation required to provide 4 mg/kg doses for children age \< 12 years.