New study aims to shield transplant patients from deadly fungal infections
NCT ID NCT06541067
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether the antifungal drug posaconazole can prevent serious fungal infections in 30 adults with blood cancer who are receiving a stem cell transplant from a donor. These patients are at high risk because of newer transplant methods. The study will check if enough of the drug stays in the blood to be effective, with close monitoring during the first weeks after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- posaconazole
- What this could lead to
- If successful, this could show that posaconazole effectively prevents dangerous fungal infections in high-risk transplant patients, leading to better infection control guidelines.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply to all patients. Posaconazole can be under-dosed, and side effects or drug interactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient ≥ 18 years of age. There is no maximum age for inclusion * Allo-CSH transplant for hematologic malignancy or benign hemopathy of any type with one or more high risk IFI criteria: * alternative donor (haploidentical intra-family donor, mismatch file donor, placental blood) * sequential conditioning for disease not in remission at the time of transplantation * use of post-transplant cyclophosphamide (PTCY) for GVH prophylaxis * patient who has previously received a HSC allograft * Written informed consent prior to protocol initiation * ECOG \<=2 * Female of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for 12 months after posaconazole discontinuation * Men of childbearing age with effective contraception during treatment and for 6 months after stopping posaconazole. * Hepatitis B, C and HIV serologies negative. * Social security affiliation Exclusion Criteria: * Patients with a history of IFI, whether active or resolved at the time of allografting * Patient with known intolerance to posaconazole * Patients with concomitant treatments FORBIDDING association with posaconazole: ergot alkaloids, CYP3A4 substrates (terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine), HMG-CoA reductase inhibitors (simvastatin, lovastatin and atorvastatin) or any other contraindicated treatment listed in VIDAL * patients with congenital or acquired QTc prolongation (QTc \>470ms) * Cardiac: systolic ejection fraction \< 50% by transthoracic ultrasound or isotopic method (isotopic gamma-angiography) * Respiratory: DLCOc \<40% of theoretical on EFR * Renal: creatinine clearance \< 50 ml/min (assessed using MDRD method) * Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal * Pregnant or breast-feeding women, * Women or men of childbearing age without effective contraception * Serious, uncontrolled concomitant infections * Yellow fever vaccination within the last year * Patient protected by law (guardianship, curatorship, safeguard of justice) * Psychological, family, sociological or geographical conditions that may hinder compliance with the study protocol and follow-up schedule * Patient who does not speak or understand French * Participation in any other therapeutic study with an exclusion period still in effect at the time of inclusion or planned participation in another therapeutic study while taking posaconazole
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Nantes
RECRUITINGNantes, France, 44000, France
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