CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Posaconazoledrug
Likely dose
Posaconazole 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00936117
NCT00936117Phase 2Completed
CompareCT.gov

Phase II Study of the Pharmacokinetics of Posaconazole Prophylaxis in Relapsed or Refractory Patients With Acute Leukemia

M.D. Anderson Cancer Center·interventional·Posted Jul 9, 2009·Updated Feb 27, 2019

In Brief

A Phase 2 clinical trial evaluating Posaconazole for Leukemia and Fungal Infection. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Fungal Infection
CountriesUnited States
CollaboratorsSchering-Plough

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 9, 2009
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.0 years ago

Interventions

Posaconazoledrug

200 mg (liquid) by mouth 3 times per day.