Study of Posaconazole for Preventing Fungal Infections in Patients Receiving Stem Cell Transplants for Blood Cancer

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What is this study about?

This clinical trial is focused on patients who are receiving a type of treatment called a hematopoietic stem cell allograft, which is a procedure where patients receive blood-forming stem cells from a donor. This study is particularly for those at high risk of developing serious infections caused by fungi, known as invasive fungal infections. The treatment being studied is a medication called posaconazole, which is used to prevent these infections. Posaconazole is available in two forms: a concentrate for solution for infusion, which is given through a vein, and a gastro-resistant tablet, which is taken by mouth.

The purpose of the study is to understand how well posaconazole works in preventing fungal infections in these patients. Participants will receive posaconazole for a period of time, and the study will monitor how much of the drug remains in their blood after a week of treatment. This helps to determine if the medication is being absorbed properly and is at a level that can effectively prevent infections. The study will also keep track of any side effects or issues with taking the medication, as well as the overall health and recovery of the patients during and after the treatment period.

Throughout the study, patients will be closely monitored by healthcare professionals. This includes regular check-ups to assess any symptoms that might suggest problems with absorbing the medication, such as nausea or diarrhea. The study will also look at how well patients stick to their treatment plan and any other medications they might be taking. The goal is to ensure that posaconazole is safe and effective for preventing fungal infections in patients undergoing stem cell transplants.

1 initiation of treatment

Upon joining the study, the treatment with posaconazole begins. This medication is used to prevent fungal infections in patients receiving a stem cell transplant.

The initial administration of posaconazole is given intravenously. This means the medication is delivered directly into the bloodstream through a vein.

2 oral administration

After the initial intravenous administration, posaconazole is taken orally. This involves swallowing the medication in the form of a solution.

The oral administration continues daily for the duration of the study, ensuring consistent levels of the medication in the body.

3 monitoring and assessment

On the 8th day of treatment, the concentration of posaconazole in the blood is measured. This is to ensure that the medication is at an effective level.

Regular monitoring continues up to Day 100, with assessments twice a week during hospitalization and once a week after discharge.

4 symptom and adherence tracking

During the study, any symptoms such as nausea, vomiting, or diarrhea are recorded. The intensity of these symptoms is assessed using a standardized scale.

Adherence to the medication regimen is monitored daily while hospitalized and weekly after discharge to ensure the treatment is followed correctly.

5 evaluation of treatment effects

The study evaluates the effectiveness of posaconazole in preventing fungal infections by monitoring various health indicators.

This includes tracking any adverse effects, the success of the stem cell transplant, and overall survival rates.

6 completion of study

The study is expected to conclude by October 15, 2027. At this point, all data collected will be analyzed to determine the success of the treatment.

Participants will be informed of the study’s findings and any implications for their ongoing care.

Who Can Join the Study?

Patient must be 18 years or older. There is no maximum age limit.
Patient is scheduled to receive an allo-HSC transplant for any blood-related cancer or non-cancerous disease with one or more high-risk criteria for IFI (invasive fungal infection). These criteria include:
- Using an alternative donor such as a partially matched family donor, mismatched donor from a registry, or umbilical cord blood.
- Sequential conditioning for a disease that is not in remission at the time of transplant.
- Use of post-transplant cyclophosphamide (PTCY) to prevent GVH (graft-versus-host) disease.
- Patient has previously received a HSC allograft (stem cell transplant).
Patient must provide written informed consent before starting the study.
Patient must have an ECOG (Eastern Cooperative Oncology Group) performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Females of childbearing age must have a negative pregnancy test and use highly effective contraception during treatment and for 12 months after stopping the medication posaconazole.
Males of childbearing age must use highly effective contraception during treatment and for 6 months after stopping posaconazole.
Patient must have negative tests for Hepatitis B, C, and HIV.
Patient must be affiliated with social security.

Who Cannot Join the Study?

Patients who are not adults.
Patients who are not due to receive an allograft, which is a type of transplant, for a blood-related cancer.
Patients who do not have a donor that is a close match in terms of HLA, which is a set of proteins important for the immune system.
Patients who do not have a donor from their family or from an international donor registry.
Patients who are not being treated in the hematology departments of the Nantes University Hospital.

Where you can join this trial?

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Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.10.2024

Trial locations

Investigated drugs:

Posaconazole

Posaconazole is a medication used in this study to prevent fungal infections in patients who have received a hematopoietic stem cell transplant. The study aims to determine how many patients have an effective level of this medication in their system after one week of treatment.

Investigated diseases:

Allogenic stem cell transplantation

Myeloid Hematological Malignancy – This term refers to a group of cancers that originate in the blood-forming cells of the bone marrow. These malignancies can affect the production and function of blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses as abnormal cells multiply and crowd out healthy cells, potentially spreading to other parts of the body. Over time, this can lead to complications such as anemia, increased risk of infections, and bleeding disorders. The progression and symptoms can vary depending on the specific type of myeloid malignancy.

Lymphoid Hematological Malignancy – This category includes cancers that develop in the lymphatic system, which is part of the immune system. These malignancies can cause the lymph nodes, spleen, and other lymphoid tissues to become enlarged. As the disease progresses, it can lead to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The abnormal lymphoid cells can spread to other parts of the body, affecting the function of various organs. The progression and impact on the body can differ based on the specific type of lymphoid malignancy.

Trial ID:

2024-511507-42-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Posaconazole for Preventing Fungal Infections in Patients Receiving Stem Cell Transplants for Blood Cancer

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