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Hematology patients are at high risk for invasive fungal infection (IFI) and are being treated with voriconazole (VOR) at Princess Margaret Hospital (PMH). It is critical that patients' serum drug levels are within therapeutic ranges when undergoing treatment. The primary objective of this study is to determine whether clinical responses (complete/partial/failure) directly correlate with patients' blood VOR drug levels.
In patients whose disease progression is associated with inadequate voriconazole (VOR) drug levels, serum drug level determination can allow for dose adjustment, thereby preventing disease progression. Patients who are extensive metabolizers may have subtherapeutic VOR levels leading to treatment failure whereas, poor metabolizers may have high drug levels that cause toxicity. Isoenzyme such as CYP2C19 exhibits genetic polymorphism. Genotyping tests can also be helpful in determining patient risk subjecting to extreme spectrum of drug levels.
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| Measure | Description | Time Frame |
|---|---|---|
| To determine whether clinical responses (complete/partial/failure) directly correlate with patients' blood voriconazole levels. | The primary outcome measure is defined by the following endpoints:
| 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective of this study will focus on clinical toxicity, organ involvement and survival. | The secondary outcome of the study is defined as resolution of renal or hepatic dysfunction and survival. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Acute leukemia (including myelogenous and lymphocytic) patients for remission induction chemotherapy, reinduction chemotherapy and consolidation chemotherapy whose antifungal treatment includes voriconazole.
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| Name | Affiliation | Role |
|---|---|---|
| Jack Seki, P.Ph, PharmD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
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