RecruitingRare disease

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 4
Scheduled visits
Regular visits are scheduled to monitor health status and treatment response.
Compliance with the treatment plan and study procedures is required.
Step 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 trial?

10 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Instytut Hematologii I Transfuzjologii
Verified
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie
Verified
Lublin, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Verified
Cracow, Poland

Trial locations

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Investigated drugs

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.

Ruxolitinib

What is already known about the treatment

Ruxolitinib – Ruxolitinib is administered orally in the form of tablets. It is currently used in medicine for the treatment of myelofibrosis, a type of bone marrow disorder. The medication works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the signaling pathways that control blood cell production and immune function. Ruxolitinib is classified as a JAK inhibitor and is well-documented in medical literature for its effectiveness in managing symptoms and improving quality of life in patients with myelofibrosis.

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