Clinical trial · Interventional
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
Phase II Study of the Pharmacokinetics of Posaconazole Prophylaxis in Relapsed or Refractory Patients With Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fungal Infection | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Posaconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Posaconazole
- description
- Posaconazole 200 mg (liquid) by mouth 3 times per day.
- interventionNames
- Drug: Posaconazole
Primary outcomes (1)
- measure
- Maximum Observed Concentration in Plasma (Cmax)
- timeFrame
- Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.
- description
- Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day. Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 - 5000 ng/ml. There are no established therapeutic ranges for posaconazole.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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) 2. Age \> 18 years and able to take oral intake. 3. Patients must sign an informed consent. 4. Patients agree to medically approved forms of contraception 5. 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: 1. Patients with history of anaphylaxis attributed to azole compounds 2. Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (EORTC criteria) 3. 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. 4. Patients receiving any medication that is contraindicated with the use of posaconazole 5. Patients with baseline creatinine levels NCI grade 3 or above (\> 3.0 - 6.0 X ULN) 6. Patients with baseline QTc prolongation NCI grade 1 or above (QTc \> 0.45 - 0.47 seconds).
References
Publications (0)
Data not yet available