Phase 3
N=489
Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
Antifungal Prophylaxis of Invasive Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00289991 ↗Enrolled (actual)
489
Serious AEs
42.1%
Results posted
Mar 2010
Primary outcome: Primary: Success at Day 180: Percent of Responders (Randomization Strata) — 59.1; 44.7; 52.5; 25.9 percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Itraconazole (Drug); Vfend - voriconazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success at Day 180: Percent of Responders (Randomization Strata) |
59.1; 44.7; 52.5; 25.9; 34.5; 28.1 | — |
| SECONDARY Success at Day 100: Percent of Responders (Randomization Strata) |
65.2; 50.6; 55.9; 27.6; 43.1; 38.6 | — |
| SECONDARY Time to Breakthrough Invasive Fungal Infection (IFI) |
119.0; 77.0 | — |
| SECONDARY Percent of Subjects With Occurrence of Breakthrough IFI |
0.9; 1.2; 1.3; 1.7 | 0.7114 |
| SECONDARY Survival: Percent of Subjects Who Died at or Before Day 180 |
15.6; 15.4 | — |
| SECONDARY Time to Discontinuation of Study Treatment |
88.7; 71.5 | 0.0026 sig |
| SECONDARY Survival: Percent of Subjects Who Died Within 1 Year |
25.9; 30.7 | 0.2487 |
| SECONDARY Duration of Treatment |
96.0; 68.0 | — |
| SECONDARY Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment |
40.6; 49.4 | 0.0570 |
Summary
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
Eligibility Criteria
Inclusion Criteria
- Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
- Male and Female over 12 years or greater
Exclusion Criteria
- Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
- Previous history of zygomycosis
- Anticipated survival less than one month
Data sourced from ClinicalTrials.gov (NCT00289991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.