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Clinical Trial NCT06541067 (POSALLO) for Hematologic Malignancy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI) (POSALLO) Phase 2 30

Recruiting
Clinical Trial NCT06541067 (POSALLO) is designed to study Treatment for Hematologic Malignancy. It is a Phase 2 interventional study that is recruiting, having started on 8 November 2024, with plans to enroll 30 participants. Led by Nantes University Hospital, it is expected to complete by 8 November 2028. The latest data from ClinicalTrials.gov was last updated on 26 January 2026.
Brief Summary
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...Show More
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/myelodyspl...Show More
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

Conditions
Hematologic Malignancy
Other Study IDs
  • POSALLO
  • RC23_0186
NCT ID Number
NCT06541067
Start Date (Actual)
2024-11-08
Last Update Posted
2026-01-26
Completion Date (Estimated)
2028-11-08
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Hematopoietic stem cell allograft (Allo-CSH)
Posaconazole
Pharmacology
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPosaconazole
Posaconazole
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
On the 8th day of treatment (i.e. after 7 days of treatment)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Monitoring of residual plasma concentrations [C]min
Weekly residual plasma concentrations of posaconazole
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
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
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
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
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.
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
From posaconazole baseline up to Day 100
Description of invasive fungal infections occurring
Description of IFI cases according to EORTC classification
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)
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
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
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
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
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
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
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
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)
Up to Day100 and 1 year post-transplant
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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

  • 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
Nantes University Hospital logoNantes University Hospital
Study Central Contact
Contact: Amandine LE BOURGEOIS, MD, 02 40 08 32 71, [email protected]
1 Study Locations in 1 Countries

France

CHU Nantes, Nantes, France, 44000, France
Amandine LE BOURGEOIS, MD, Contact, 02 40 08 32 71, [email protected]
Recruiting