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PTX3 genetically stratified randomized double-blinded allocation event-driven clinical trial for antifungal prophylaxis in patients with acute myeloid leukemia
EU CTIS ID: 2024-517211-79-00
What this study is testing
The main objective is to demonstrate that, in the high risk strata, the probability of experiencing proven and probable invasive mold infections during the treatment period (days 0-180) in AML/MDSit patients treated with posaconazole is lower than in patients treated with fluconazole, i.e the absolute risk reduction (ARR) is greater than 0.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent according to national/local regulations
- Age ≥18 years
- Diagnosis of AML or MDSit (de novo or secondary) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage chemotherapy
- Planned hospital admission for the duration of the neutropenic phase (ANC<500 cells/mm3)
You likely can't join if
- Patients with neutropenia (ANC<500 cells/mm3) at hospital admission (first inpatient blood analysis)
- Receipt of a prior allogeneic HCT
- Previous exposure to mold-active prophylaxis (>48 hours within 7 days of inclusion).
- Patients with relapsed leukemia already included in the trial
- Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3
- Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals
See the full eligibility criteria
- Signed informed consent according to national/local regulations
- Age ≥18 years
- Diagnosis of AML or MDSit (de novo or secondary) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage chemotherapy
- Planned hospital admission for the duration of the neutropenic phase (ANC<500 cells/mm3)
- Patients with neutropenia (ANC<500 cells/mm3) at hospital admission (first inpatient blood analysis)
- Receipt of a prior allogeneic HCT
- Previous exposure to mold-active prophylaxis (>48 hours within 7 days of inclusion).
- Patients with relapsed leukemia already included in the trial
- Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3
- Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals
- Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast feeding
- Diagnosis and treatment for an IFI within 3 months prior to study enrolment and an IMI at any point prior to or at the time of enrolment
- Severe liver dysfunction, defined as at least one of the following markers: AST, ALT, alkaline phosphatase, and/or total bilirubin above >5x upper limit of normality documented on the first inpatient analysis if still present at inclusion and considered contra-indicated by the clinical team
- Patients with a prolonged QTc interval on at least 2 electrocardiograms (ECG): QTc greater than 450 msec for men and greater than 470 msec for women, and if considered contra-indicated by the clinical team
- Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine (because of the possibility of QT prolongation), sirolimus, rifampin, rifabutin, carbamazepine, long acting barbiturates (e.g., phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (e.g., ergotamine, dihydroergotamine)
- Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.