Study for Myelofibrosis Patients Using Ruxolitinib or Ruxolitinib with Other Cancer Treatments

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What is this study about?

This clinical trial is focused on studying the disease known as Myelofibrosis, a type of bone marrow cancer that affects the body’s ability to produce blood cells. The treatment being used in this study is a medication called Ruxolitinib, which is available in tablet form under the brand name Jakavi. The study involves two different strengths of the medication: 5 mg and 15 mg tablets. The purpose of the study is to allow patients who were previously part of other studies involving Ruxolitinib to continue their treatment and to monitor the safety of the medication.

Participants in this study may receive Ruxolitinib alone, in combination with other cancer treatments, or continue with their existing cancer therapy. The study is designed to ensure that patients who are benefiting from Ruxolitinib can maintain their treatment regimen. The study will track the occurrence of any side effects or serious health events that may arise during the treatment period.

The study is open-label, meaning that both the researchers and participants know which treatment is being administered. This trial will continue until 2026, providing ongoing access to the medication for those who are already benefiting from it. Participants will be required to attend scheduled visits and follow the treatment plan as outlined by the study protocol.

1 joining the study

Participation begins after enrollment in a previous study of ruxolitinib has been completed or terminated.

Eligibility requires current treatment with ruxolitinib or a combination of ruxolitinib and other cancer therapies, with demonstrated benefit and stable disease.

2 treatment continuation

The study provides continued access to ruxolitinib treatment.

Treatment involves taking Jakavi tablets, available in 15 mg and 5 mg doses, administered orally.

The dosage and frequency are determined by the healthcare provider based on individual needs and previous treatment response.

3 safety evaluation

The study aims to evaluate the safety of ongoing treatment with ruxolitinib.

Monitoring includes assessing the frequency and types of any adverse events experienced during the study.

4 scheduled visits

Regular visits are scheduled to monitor health status and treatment response.

Compliance with the treatment plan and study procedures is required.

5 study duration

The study is estimated to continue until May 31, 2026.

Participation involves adherence to the study protocol until the end date or until the healthcare provider determines it is no longer beneficial.

Who Can Join the Study?

Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of ruxolitinib that has completed or been terminated.
Currently tolerating treatment in the parent protocol. This means the patient is handling the treatment well without severe side effects.
Currently benefiting from the treatment with ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone, as determined by the investigator. This means the treatment is helping the patient, according to the doctor’s assessment.
Have at least stable disease, as determined by the investigator. This means the disease is not getting worse.
Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. This means the patient has been following the study rules and instructions.
Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol. This means the patient agrees to attend all appointments and follow the treatment plan.
Willingness to avoid pregnancy or fathering children based on specific criteria. This includes:
- Woman of nonchildbearing potential.
- Woman of childbearing potential who has a negative pregnancy test and agrees to use effective birth control methods.
- Man who agrees to use effective birth control methods to avoid fathering children.
Ability to comprehend and willingness to sign an informed consent form (ICF). This means the patient understands the study and agrees to participate by signing a consent form.

Who Cannot Join the Study?

Patients who have a different condition than myelofibrosis cannot participate. Myelofibrosis is a type of blood cancer that affects the bone marrow.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Both male and female patients can participate, but those who do not meet other criteria cannot join.
Patients who are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	31.07.2024

Trial locations

Investigated drugs:

Ruxolitinib

Ruxolitinib is a medication used in this clinical trial to provide continued treatment for participants who were previously enrolled in studies involving this drug. It is often used to treat certain types of cancer by inhibiting specific enzymes that contribute to the growth of cancer cells. In this trial, participants may receive ruxolitinib alone or in combination with other cancer therapies.

Background Cancer Therapy refers to the standard treatments that participants may be receiving alongside ruxolitinib. These therapies are tailored to the individual’s specific type of cancer and may include chemotherapy, radiation therapy, or other targeted treatments. The trial aims to evaluate the safety and effectiveness of continuing these therapies in combination with ruxolitinib.

Investigated diseases:

Myelofibrosis

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 condition is chronic and can vary greatly in its progression among individuals.

Trial ID:

2023-507225-42-00

Protocol code:

INCB 18424-270

NCT ID:

NCT02955940

Trial Phase:

Therapeutic exploratory (Phase II)

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Study for Myelofibrosis Patients Using Ruxolitinib or Ruxolitinib with Other Cancer Treatments

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