Hematologic MalignancyPhase 2POSALLONCT06541067

Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI)

A Phase 2 study testing Posaconazole in people with Hematologic Malignancy, run by Nantes University Hospital at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Malignancy
What is being tested?: Posaconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteFrance
Study dates: 8 Nov 2024to 8 Nov 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amandine LE BOURGEOIS, MD contact

02 40 08 32 71 ext. +33

amandine.lebourgeois@chu-nantes.fr

France1 site, 1 recruiting

CHU Nantes
Nantes, France, 44000
Amandine LE BOURGEOIS, MD, 02 40 08 32 71 ext. +33, amandine.lebourgeois@chu-nantes.fr
Recruiting

Other trials in France

About this study

Official title: Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI): POSALLO Study

Patients receiving an allogeneic hematopoietic stem cell transplant (allo-CSH) are at high risk of infection, particularly of fungal origin. Until the 2018 recommendations of the 6th European Conference on Infections in Leukemia (ECIL6), primary prophylaxis of invasive fungal infections (IFI), in allograft patients, was based on the administration of fluconazole until D100. Due to changes in transplantation practices (alternative donor transplantation, sequential transplantation, etc.) and changes in microbiological ecology (increased incidence of IFIs caused by filamentous germs such as aspergillosis and mycormycosis), fluconazole prophylaxis is now sometimes suboptimal. It is therefore recommended that patients at high risk of developing IFIs should be given azole molecules with activity against filamentous agents as primary prophylaxis during the first 3 months after transplantation.

Posaconazole is often under-dosed (below the minimum effective concentration). It therefore seems essential to carry out a prospective study with close [C]min dosing in the specific situation of allograft patients, a population that appears to be at risk of underdosing in the light of initial retrospective analysis results.

Read the detailed description

There are several treatments based on azole molecules: voriconazole, posaconazole, isavuconazole... To date, none of these treatments has been approved for primary post-allograft prophylaxis. Posaconazole is indicated in cases of graft-versus-host disease (GVHD) (requiring systemic corticosteroid therapy after allo-CSH), and as primary prophylaxis during aplasia in patients with acute myeloblastic leukemia/myelodysplasia (AML/MDS). Other azole molecules are not approved for primary prophylaxis, and may give rise to drug interactions with certain treatments prescribed for allograft patients (e.g. ciclosporin, letermovir).

Although recommendations for the administration of posaconazole as primary prophylaxis post allo-CSH have been in place for 4 years, few studies are available to date. The adult hematology department of Nantes University Hospital conducted a retrospective study of 70 allograft patients at high risk of IFI between 04/2020 and 12/2021. Posaconazole treatment was administered from D0 (or the day after the 2nd dose of post-transplant cyclophosphamide) to D100. Treatment was generally well tolerated, with discontinuation due to possible treatment toxicity in 12.6% of cases, mainly of hepatic origin (n=7). Posaconazole was resumed in 2 cases without recurrence of toxicity. In 84.2% of patients, no IFI was observed. One of the limitations of this study was the low number of determinations of residual posaconazole concentration ([C]min). In fact, [C]min was carried out in only 59 patients/70, with a median delay of 9 days. In 43% of cases, the [C]min was insufficient (< 0.5 mg/L), which is significantly lower than the [C]min obtained in patients with AML/MDS undergoing induction ([C]min< 0.5 mg/L: 5% of patients). It therefore seems essential to carry out a prospective study with close [C]min measurement in the specific situation of allograft patients, a population that appears to be at risk of underdosing in the light of the initial retrospective results of analyses.

Conditions: Hematologic Malignancy
Being tested: Posaconazole
Keywords: Hematopoietic stem cell allograft (Allo-CSH), Posaconazole, Pharmacology
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PosaconazoleDrug
Per Os, on Day 0 of allo-CSH if the patient's condition permits, or after the last dose of immunosuppressor (post-transplant cyclophosphamide) (Day+5 or Day+6 depending on protocols).
On the first day of treatment: 300 mg in the morning (= 3 x 100 mg tablets) and 300 mg in the evening (= 3 x 100 mg tablets), then from day 2 of treatment: 300 mg per day (= 3 x 100 mg tablets) in a single dose

Study groups in NCT06541067
Study group	Role	What they receive
Posaconazole	Experimental	Not described Receives: Drug: Posaconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Effective residual concentration of posaconazole
The main objective is to study, in the early phase after allo-CSH, the percentage of patients who have an effective residual concentration of posaconazole.
The primary endpoint is plasma residual posaconazole concentration ([C]min), measured on day 8 of posaconazole initiation. A [C]min > 0.7mg/l is considered effective.
Measured: On the 8th day of treatment (i.e. after 7 days of treatment)

Secondary outcomes (17)

Monitoring of residual plasma concentrations [C]min
Weekly residual plasma concentrations of posaconazole
Measured: From posaconazole baseline up to Day100
Description of circumstances leading to posaconazole underdosing
A clinical record will be taken twice a week during hospitalization and then once a week to describe clinical symptoms leading to malabsorption: nausea, vomiting, diarrhea, mucositis, colitis. Symptom intensity will be assessed according to the NCI CTCAE v5 classification
Measured: From posaconazole baseline up to Day100
Description of circumstances leading to posaconazole underdosing
Adherence to treatment will be monitored daily during hospitalization by paramedical staff. Once home, adherence will be assessed once a week by the doctor in charge of the patient
Measured: From posaconazole baseline up to Day100
Description of circumstances leading to posaconazole underdosing
All co-medications should be recorded throughout the course of posaconazole treatment, based on data from the patient's medical record
Measured: From posaconazole baseline up to Day100
Description of the reasons for administering posaconazole intravenously (IV)
The physician in charge of the patient should specify the reason(s) for IV administration of the treatment
Measured: From posaconazole baseline up to Day100
Description of situations leading to initial non-administration or early discontinuation of posaconazole
The physician in charge of the patient should specify the situation(s) that led to non-administration or early discontinuation of treatment.
Measured: From posaconazole baseline up to Day100
Description of situations leading to initial non-administration or early discontinuation of posaconazole
Description of posaconazole-related toxicities according to NCI CTCAE v5 classification
Measured: From posaconazole baseline up to Day 100
Description of invasive fungal infections occurring
Description of IFI cases according to EORTC classification
Measured: From posaconazole baseline up to 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study)
Description of patient outcome: incidence of engraftment
Engraftment assessed on hematological reconstitution (number of days of aplasia with PNN <0.5 G/L and platelets < 20, number of platelet and packed cell transfusions)
Measured: Month 1 post-transplant
Description of patient outcome: overall survival (OS)
Survival between day 0 of transplantation and date of death or last follow-up
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or death
Description of patient outcome: disease-free survival (DFS)
Survival between day 0 of transplant and date of relapse, death or last follow-up
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or documented relapse or death whicvever came first
Description of patient outcome: non-relapse mortality (NRM)
Any death unrelated to relapse or disease progression
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or death, whichever came first
Description of patient outcome: incidence of relapse (IR)
Any documented disease recurrence
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or any documented disease recurrence, whichever came first
Description of patient outcome: cumulative incidence of acute GVHD
Acute GVH grade 2-4 according to Mount Sinai criteria
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study)
Description of patient outcome: cumulative incidence of chronic GVHD
Extensive chronic GVH according to NCI criteria
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study)
Description of patient outcome: GVHD-free relapse-free survival (GRFS)
Median relapse-free survival without grade 3-4 acute GVHD or chronic GVHD requiring systemic treatment
Measured: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or death
Grade 3 and 4 post-transplant adverse events
Post-transplant grade 3 and 4 adverse events (dates of occurrence) (NCI CTCAE version 5 criteria)
Measured: Up to Day100 and 1 year post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 20248 Nov 2028

First posted7 Aug 2024
Study start8 Nov 2024
Primary completion15 Jan 2027 (estimated)
Study completion8 Nov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
More trials run by Nantes University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06541067
Sponsor's protocol ID: RC23_0186
Acronym: POSALLO
Status last verified: Jan 2026
First submitted: 24 Jul 2024
Last updated: 26 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Amandine LE BOURGEOIS, MD

02 40 08 32 71 ext. +33

amandine.lebourgeois@chu-nantes.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI): POSALLO Study
ClinicalTrials.gov ID: NCT06541067
Acronym / sponsor ID: POSALLO / RC23_0186
Conditions: Hematologic Malignancy
Keywords: Hematopoietic stem cell allograft (Allo-CSH), Posaconazole, Pharmacology
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Nantes University HospitalUniversity, hospital or other
Study start: 8 Nov 2024 (actual)
Primary completion: 15 Jan 2027 (estimated)
Study completion: 8 Nov 2028 (estimated)
First posted: 7 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Posaconazole	Experimental	Drug: Posaconazole

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:
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

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PosaconazolePer Os, on Day 0 of allo-CSH if the patient's condition permits, or after the last dose of immunosuppressor (post-transplant cyclophosphamide) (Day+5 or Day+6 depending on protocols). On the first day of treatment: 300 mg in the morning (= 3 x 100 mg tablets) and 300 mg in the evening (= 3 x 100 mg tablets), then from day 2 of treatment: 300 mg per day (= 3 x 100 mg tablets) in a single dose	Drug	Posaconazole

Primary outcome

Effective residual concentration of posaconazole
Time frame: On the 8th day of treatment (i.e. after 7 days of treatment)
The main objective is to study, in the early phase after allo-CSH, the percentage of patients who have an effective residual concentration of posaconazole. The primary endpoint is plasma residual posaconazole concentration ([C]min), measured on day 8 of posaconazole initiation. A [C]min > 0.7mg/l is considered effective.

17 secondary outcomes

Monitoring of residual plasma concentrations [C]min
Time frame: From posaconazole baseline up to Day100
Description of circumstances leading to posaconazole underdosing
Time frame: From posaconazole baseline up to Day100
Description of circumstances leading to posaconazole underdosing
Time frame: From posaconazole baseline up to Day100
Description of circumstances leading to posaconazole underdosing
Time frame: From posaconazole baseline up to Day100
Description of the reasons for administering posaconazole intravenously (IV)
Time frame: From posaconazole baseline up to Day100
Description of situations leading to initial non-administration or early discontinuation of posaconazole
Time frame: From posaconazole baseline up to Day100
Description of situations leading to initial non-administration or early discontinuation of posaconazole
Time frame: From posaconazole baseline up to Day 100
Description of invasive fungal infections occurring
Time frame: From posaconazole baseline up to 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study)
Description of patient outcome: incidence of engraftment
Time frame: Month 1 post-transplant
Description of patient outcome: overall survival (OS)
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or death
Description of patient outcome: disease-free survival (DFS)
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or documented relapse or death whicvever came first
Description of patient outcome: non-relapse mortality (NRM)
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or death, whichever came first
Description of patient outcome: incidence of relapse (IR)
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or any documented disease recurrence, whichever came first
Description of patient outcome: cumulative incidence of acute GVHD
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study)
Description of patient outcome: cumulative incidence of chronic GVHD
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study)
Description of patient outcome: GVHD-free relapse-free survival (GRFS)
Time frame: Up to Day100 and 1 year post-transplant and/or through study completion (end of follow-up at the last visit of the last patient included in the study) or death
Grade 3 and 4 post-transplant adverse events
Time frame: Up to Day100 and 1 year post-transplant

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Individual participant dataSharing planned: No

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Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Amandine LE BOURGEOIS, MD contact

02 40 08 32 71 ext. +33

amandine.lebourgeois@chu-nantes.fr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Posaconazole in people with Hematologic Malignancy, run by Nantes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amandine LE BOURGEOIS, MD (02 40 08 32 71 ext. +33, amandine.lebourgeois@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effective residual concentration of posaconazole (time frame: On the 8th day of treatment (i.e. after 7 days of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06541067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.