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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed Informed Consent according to national/local regulations.

• Age ≥18 years.

• Diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome in transformation (MDSit) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage remission chemotherapy.

• Planned hospital admission for the duration of the neutropenic phase (absolute neutrophils count \<500 cells/mm3).

Locations
Other Locations
Belgium
AZ Sint-Jan Hospital
RECRUITING
Bruges
Ghent University Hospital
RECRUITING
Ghent
University Hospital Leuven (UZ Leuven)
RECRUITING
Leuven
France
Henri Mondor Hospital
RECRUITING
Créteil
Switzerland
Cantonal Hospital Aarau
RECRUITING
Aarau
University Hospital Basel
RECRUITING
Basel
Cantonal Hospital HFR
RECRUITING
Fribourg
University Hospital of Geneva (HUG)
RECRUITING
Geneva
University Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Contact Information
Primary
Pierre-Yves Bochud, MD
Pierre-Yves.Bochud@chuv.ch
0041 213144379
Time Frame
Start Date: 2019-02-11
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 320
Treatments
Other: high-risk PTX3 SNPs
risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): homozygous for rs230561 and/or rs381652
Other: low-risk PTX3 SNPs
risk predicted by genotyping two PTX3 single nucleotide polymorphisms (SNPs): other than homozygous for rs230561 and/or rs381652
Sponsors
Collaborators: Swiss National Science Foundation
Leads: Bochud Pierre-Yves

This content was sourced from clinicaltrials.gov