BridgeMD
New treatment option for Hematologic Malignancy
Official title Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI)
ClinicalTrials.gov ID: NCT06541067
What this study is testing
What is Posaconazole?
Posaconazole is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hematologic malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.