Continued Treatment Study for Patients with Myelofibrosis, Post-Lung Transplant BOS, or Chronic Graft-Versus-Host Disease Using Itacitinib

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What is this study about?

This clinical trial is focused on providing continued treatment for participants who have been previously enrolled in studies involving the medication Itacitinib (also known by its code name INCB039110). The diseases being studied in this trial include Myelofibrosis, a condition where scar tissue forms in the bone marrow, chronic graft-versus-host disease, which can occur after a stem cell or bone marrow transplant, and bronchiolitis obliterans syndrome (BOS) that can develop after a lung transplant.

The purpose of this study is to continue evaluating the safety of Itacitinib for participants who are experiencing clinical benefits from this treatment. Participants will continue to receive the medication in tablet form, taken orally, as part of their ongoing care. The study is designed to monitor any side effects or adverse events that may occur while participants are on this medication.

Throughout the study, participants will have scheduled visits to ensure their treatment is progressing safely and effectively. The study aims to provide a seamless transition for those who have been benefiting from Itacitinib in previous trials, allowing them to continue their treatment under careful observation. The study is expected to run until 2027, ensuring long-term support and monitoring for participants.

1 enrollment confirmation

Upon joining the study, confirm that you are currently enrolled and receiving treatment in an Incyte-sponsored itacitinib-based clinical study.

Ensure that you are tolerating the treatment as defined by the previous study protocol and are receiving clinical benefit from the itacitinib-based treatment.

2 compliance verification

Demonstrate compliance with the requirements of the previous study protocol, as assessed by the investigator.

Express willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.

3 treatment continuation

Continue receiving treatment with itacitinib in tablet form, administered orally.

The dosage, frequency, and duration of administration will be determined by the study protocol and the investigator’s assessment.

4 safety evaluation

Participate in regular assessments to evaluate the safety of the treatment.

Report any adverse events (AEs) or serious adverse events (SAEs) experienced during the study.

5 study completion

The study is estimated to end on May 31, 2027.

Continue to follow the study protocol and attend all scheduled visits until the study’s completion.

Who Can Join the Study?

Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB 39110)-based clinical study (parent protocol). Itacitinib is a type of medication used in the study.
Currently tolerating treatment as defined by the parent protocol. This means the patient is handling the treatment well according to the study’s rules.
Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator. This means the treatment is helping the patient, as judged by the study doctor.
Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. This means the patient has been following the study’s rules and instructions.
Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol. The patient agrees to attend all appointments and follow the treatment plan.
Willingness to avoid pregnancy or fathering children based on criteria in Section 5.1. The patient agrees to take steps to prevent pregnancy during the study.
Ability to comprehend and willingness to sign an ICF. ICF stands for Informed Consent Form, which is a document that explains the study and confirms the patient’s agreement to participate.

Who Cannot Join the Study?

Patients who have not been receiving clinical benefit from an itacitinib-based therapy in an Incyte-sponsored clinical study cannot participate. Itacitinib is a type of medication used in certain treatments.
Patients who have not been part of an Incyte-sponsored clinical study using itacitinib-based therapy are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Ozneqyueubyjmd Lopr Geuh	Linz	Austria
Myexdmhpcnzbxprmzdckqkofym Hosvknthfsdliisb	Halle (Saale)	Germany
Uwgbuqwxue Gbltdpy Hortrfan Agwscvu	Athens	Greece

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	31.05.2023
Belgium	Not recruiting	31.05.2023
Germany	Not recruiting	31.05.2023
Greece	Not recruiting	31.05.2023
Italy	Not recruiting	31.05.2023
Spain	Not recruiting	31.05.2023

Trial locations

Investigated drugs:

Itacitinib

Itacitinib is a medication being studied for its potential to help people with certain medical conditions. It works by targeting specific pathways in the body that are involved in inflammation and immune responses. In this clinical trial, participants who have been benefiting from itacitinib in previous studies are given the opportunity to continue their treatment. The main goal is to ensure that the medication is safe and continues to provide benefits to those who are already experiencing positive effects from it.

Investigated diseases:

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue. This process disrupts the body’s ability to produce blood cells, leading to anemia, weakness, and fatigue. As the disease progresses, the spleen and liver may enlarge due to the increased workload of producing blood cells. Patients may experience symptoms such as night sweats, fever, and bone pain. Over time, myelofibrosis can lead to severe complications related to blood cell production. The disease can evolve into acute leukemia in some cases.

Bronchiolitis Obliterans Syndrome (BOS) Post-Lung Transplant – Bronchiolitis Obliterans Syndrome is a condition that affects the small airways of the lungs following a lung transplant. It is characterized by inflammation and fibrosis, leading to the narrowing and obstruction of the airways. This results in a progressive decline in lung function, causing symptoms such as coughing, shortness of breath, and wheezing. The condition is a form of chronic lung allograft dysfunction and is a major cause of long-term morbidity in lung transplant recipients. Over time, the obstruction of airways can become severe, significantly impacting respiratory function. The progression of BOS can vary among individuals.

Chronic Graft-Versus-Host Disease – Chronic Graft-Versus-Host Disease is a complication that can occur after an allogeneic stem cell or bone marrow transplant. It arises when the donated immune cells attack the recipient’s body tissues, recognizing them as foreign. This condition can affect multiple organs, including the skin, liver, and gastrointestinal tract, leading to symptoms such as skin rashes, jaundice, and digestive issues. The disease can also cause joint pain, dry eyes, and mouth, and can impact the quality of life. The severity and progression of symptoms can vary widely among patients. Chronic Graft-Versus-Host Disease can persist for months or even years.

Trial ID:

2022-501661-47-00

Protocol code:

INCB 39110-801

Trial Phase:

Therapeutic exploratory (Phase II)

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Continued Treatment Study for Patients with Myelofibrosis, Post-Lung Transplant BOS, or Chronic Graft-Versus-Host Disease Using Itacitinib

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?