Status:
COMPLETED
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Schering-Plough
Conditions:
Leukemia
Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn the amount of posaconazole that is in the body at different time points when given to patients with leukemia. The safety of this drug will also be ...
Detailed Description
Chemotherapy can lower immune system function, which can cause fungal infections to occur more easily. The standard treatment for prevention of such infections includes drugs such as voriconazole and ...
Eligibility Criteria
Inclusion
- Patients newly diagnosed with AML or high-risk MDS undergoing induction chemotherapy or refractory or relapsed patients with AML or high-risk MDS who will receive first or second salvage chemotherapy. (Salvage patients are defined as patients that achieved remission and relapsed or patients who were refractory to initial frontline chemotherapy)
- Age \> 18 years and able to take oral intake.
- Patients must sign an informed consent.
- Patients agree to medically approved forms of contraception
- Patients on prior antifungal prophylaxis with voriconazole, itraconazole or fluconazole are eligible if they completed 3 days wash-out period if on voriconazole, or 14 days wash-out period if on itraconazole or 7 days wash-out period if on fluconazole
Exclusion
- Patients with history of anaphylaxis attributed to azole compounds
- Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (EORTC criteria)
- Patients with baseline total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or baseline SGPT \> 5 times upper limit normal.
- Patients receiving any medication that is contraindicated with the use of posaconazole
- Patients with baseline creatinine levels NCI grade 3 or above (\> 3.0 - 6.0 X ULN)
- Patients with baseline QTc prolongation NCI grade 1 or above (QTc \> 0.45 - 0.47 seconds).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00936117
Start Date
September 1 2009
End Date
September 1 2013
Last Update
February 27 2019
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030