Prophylaxis against invasive fungal infection following allogeneic hematopoietic stem cell transplantation. MedDRA version: 8 Classification code 10017533
Conditions
Interventions
Trade Name: VFEND
Product Name: VFEND
Pharmaceutical Form: Tablet
INN or Proposed INN: Voriconazole
Other descriptive name: (2R, 3S)-2-(
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: · Males or females = 12 years of age. · Subjects who will be receiving allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failure of therapy for lymphoma or transformation of chronic myeloid leukemia · Signed and dated informed consent will be obtained from each subject in accordance with the local regulatory and legal requirements · Females of childbearing potential must have a negative serum b-HCG pregnancy test and use an approved method of contraception throughout the study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following must not be included in the trial: · 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 ). · Any previous history of zygomycosis (e.g. Mucor, Absidia, Rhizopus). · Use of any systemically active antifungal agent within the 7 days prior to study entry. · Allergy to study drugs or any excipients. · Abnormal laboratory test results, defined as impaired hepatic function, as shown by transaminases or alkaline phosphatase, > 5 x Upper Limit of Normal [ULN], bilirubin >2.5mg/dL. · Severe disease other than underlying condition, likely to jeopardize the planned termination of the study (e.g. acute myocardial infarction, unstable angina pectoris, potentially pro-arrhythmic conditions such as cardiac impairment due to previous cardiotoxic chemotherapy, previous torsade de pointes, prolongation of the QT interval > 450 msec for men or > 470 msec for women). · Concomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, carbamazepine, rifampicin, phenobarbital, ritonavir or efavirenz which might interfere with the evaluation of study drugs during the study. · Alcohol and/or any other drug abuse. · Previous participation in this trial. · Unable and/or unlikely to comprehend and/or follow the protocol. · Participation in any other studies involving investigational products, concomitantly or within 30 days prior to entry in the study. · Anticipated survival less than one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the “Success” of antifungal prophylaxis with voriconazole versus itraconazole at 180 days post transplant. Success will be measured using a composite endpoint of: survival to Day 180 with no breakthrough invasive fungal infection and no discontinuation of study drug for > 14 days during the 100-day prophylaxis.; Secondary Objective: · Success of antifungal prophylaxis (as defined above), but at 100 days post transplant,and comparisons of: · Time to breakthrough invasive fungal infection. · Rates of occurrence of breakthrough invasive fungal infection. · Survival to 180 days post-transplant. · Safety and tolerability of the two study treatments. · Time to discontinuation of study treatment. · Durations of study drug treatment (solid or liquid oral formulations and IV formulation) and rates of empirical therapy. · Use of other systemic antifungal agents as empirical or therapeutic treatment. · Reasons for discontinuation of study treatment. · Survival 1 year after transplant, which will be reported separately. · Subject assessed tolerability of therapy. · Use of healthcare resources. ; Primary end point(s): Success at Day 180. This is a multi-component endpoint where all of the following must be met:· Survival until Day 180. · No breakthrough invasive fungal infection. · No discontinuation of study drug for a total of >14 out of 100 days of prophylaxis for any reason. | — |
Countries
Czech Republic, Greece, Portugal, Spain, United Kingdom
Outcome results
None listed