Phase 2
N=20
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
Leukemia · Fungal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00936117 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Maximum Observed Concentration in Plasma (Cmax) — 200; 290; 300; 580 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Posaconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration in Plasma (Cmax) |
200; 290; 300; 580; 770; 800 | — |
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 studied.
Objectives:
Primary:
To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing induction chemotherapy or relapsed or refractory patients who will receive salvage chemotherapy.
Secondary:
To evaluate the safety of posaconazole given as prophylaxis.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00936117). 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.