RecruitingNot ApplicableNCT03828773

PTX3-targeted Antifungal Prophylaxis

PTX3 Genetically Stratified Randomized Double-blinded Allocation Event-driven Clinical Trial for Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia

Sponsor

Bochud Pierre-Yves

Enrollment

410 participants

Start Date

Feb 11, 2019

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Genetic Predisposition Candidiasis Fungal Infection Aspergillosis

Summary

This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a targeted antifungal prevention strategy (guided by a patient's genetic susceptibility based on a protein called PTX3) can more effectively prevent serious fungal infections in leukemia patients whose immune system has been severely weakened by chemotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with acute myeloid leukemia (AML) or an advanced form of myelodysplastic syndrome (MDS) - You are receiving or are about to receive intensive chemotherapy (induction, consolidation, or salvage therapy) - You are expected to be hospitalized throughout your neutropenic phase (the period when your immune system is at its lowest) **You may NOT be eligible if...** - Your white blood cell count is already critically low before chemotherapy starts - You have a specific subtype called acute promyelocytic leukemia (APL or AML-M3) - You have a known allergy or serious reaction to antifungal medications (azole antifungals) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPosaconazole

Posaconazole is a triazole with broad-spectrum activity, to include Candida species, Aspergillus species, and other fungal pathogens, including the Zygomycetes. Posaconazole is available as slow release tablets (300mg/day) and as intravenous (IV) formulation (300mg/day) and is licensed and approved in Switzerland for the prevention of IFI, including mold and yeast infections, in patients \>18 years who are at high risk of developing these types of infection (patients with long-term neutropenia or HCT recipients). Furthermore, international guidelines recommend posaconazole for primary antifungal prophylaxis in high-risk patients, such as AML patients with prolonged neutropenia. Posaconazole is available in Switzerland under the name of Noxafil® in capsules of 100mg, suspension of 40mg/mL and intravenous formulation of 300mg/16.7 mL.

DRUGFluconazole

Fluconazole is an antifungal with activity against most Candida species. Fluconazole is licensed and approved in Switzerland for prophylaxis of IC in patients with neutropenia induced by chemotherapy or radiotherapy at a daily dose of 200 to 400 mg once daily. Fluconazole (200 mg or 400 mg once daily) is still currently used as primary antifungal prophylaxis (standard of care) in all 7 centers participating in this trial. Fluconazole is available in Switzerland under the name of Diflucan® in capsules of 50 mg, 150 mg and 200 mg and in powder for preparation of suspension (50 mg/5 ml and 200 mg/5 ml (forte)) or perfusion (2 mg/1 ml). Several generics of Diflucan® are authorized in Switzerland. Prescribing Diflucan® or any of its generics will remain at the discretion of and based on the standard operating procedures (SOP) at each institution.