Official Title: “Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)”

Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have has a Stem Cell Transplant. The success of the end point will be measures using evidence of Infection, drug compliance and survival.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Itraconazole
  • Prophylaxis
• Drug: Vfend - voriconazole
  • Prophylaxis

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Itraconazole
• Experimental: Voriconazole

Primary Measures

• Success at Day 180: Survival at day 180; No breakthrough invasive fungal infection; No discontinuation of study medication for greater than 14 days
  • Time Frame: 180 day
    Safety Issue?: No

Secondary Measures

• Success at day 100; Time to breakthrough IFI;
  • Time Frame: day 100
    Safety Issue?: No
• Survival at day 180;
  • Time Frame: day 180
    Safety Issue?: No
• Safety and Tolerability of two treatments; Durations of study treatments; Use of other systemic antifungal agents
  • Time Frame: ongoing
    Safety Issue?: No

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' (Asicioglu et al 2002)
• Previous history of zygomycosis
• Anticipated survival less than one month

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00289991

Study ID Number: A1501073

ClinicalTrials.gov Identifier: NCT00289991

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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