Study of Fedratinib and Nivolumab for Patients with Myelofibrosis Resistant to JAK-inhibitor Treatment

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What is this study about?

This clinical trial is focused on studying a condition called Myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study is exploring a combination treatment using two medications: Fedratinib and Nivolumab. Fedratinib is taken as a capsule, while Nivolumab is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective this combination therapy is for patients with Myelofibrosis who have not responded well to previous treatments known as JAK-inhibitors. Participants in the study will receive the combination of Fedratinib and Nivolumab over a period of time, and their response to the treatment will be monitored. The study will look at various outcomes, such as the improvement in symptoms, the need for blood transfusions, and overall quality of life.

Throughout the study, the safety of the treatment will be closely observed, including any side effects that may occur. The trial will also assess how the treatment affects the progression of the disease and the overall survival of the participants. This research aims to provide valuable insights into the potential benefits of combining Fedratinib and Nivolumab for treating Myelofibrosis.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to sign an Informed Consent Form to confirm your understanding and agreement to participate.

During this visit, your nutritional status will be assessed, and if you are a female of childbearing potential, a pregnancy test will be conducted to ensure eligibility.

2 screening and baseline assessments

You will undergo various assessments to establish baseline health data. This includes checking your thiamine levels and ensuring they are within normal limits.

Your performance status will be evaluated to ensure it is suitable for participation, and your organ function will be assessed.

3 start of treatment

The treatment involves a combination of two medications: Fedratinib and Nivolumab. Fedratinib is taken orally in the form of 100 mg hard capsules, while Nivolumab is administered through an intravenous infusion.

You will receive these medications over a series of treatment cycles, with specific dosages and schedules provided by the study team.

4 ongoing treatment and monitoring

Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes assessing your response to the medications and any side effects.

You will be asked to complete questionnaires to evaluate your quality of life and any symptoms you experience.

5 end of treatment and follow-up

After completing the treatment cycles, you will have a final assessment to evaluate the overall impact of the therapy on your condition.

Follow-up visits may be scheduled to monitor your health and any long-term effects of the treatment.

Who Can Join the Study?

Must have signed an Informed Consent Form, which means you agree to participate in the study after understanding all the details.
Must have a normal nutritional status, as determined by the doctor.
Females who can have children must take regular pregnancy tests, and the results must be negative.
If sexually active, females who can have children must use effective birth control methods unless they are completely abstaining from heterosexual intercourse.
Males, even those who have had a vasectomy, must use condoms during sexual activity with females who can have children. Males must also agree not to donate semen or sperm.
Must be 18 years of age or older.
Must be diagnosed with myelofibrosis (MF), a type of bone marrow disorder, according to specific medical criteria.
Must have a need for therapy, which could be due to symptoms affecting daily activities or specific risk levels.
Must have had no response or a suboptimal response to any JAK-inhibitor therapy, which is a type of treatment for myelofibrosis. This includes persistent symptoms or specific blood test results.
Must have an ECOG performance status of less than 3, which is a scale used to assess how a disease affects daily living abilities, and must have adequate organ function.
Must agree to use reliable contraception throughout the study and for a specified period after stopping the study medications.
Must be willing to receive blood transfusions if needed.
Must have thiamine levels (a type of vitamin) that are not below the normal limit, although prior supplementation is allowed.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 5 years, except for skin cancer that is not melanoma.
Patients who have an active infection that requires treatment with antibiotics.
Patients who have had a heart attack or stroke in the last 6 months.
Patients who have uncontrolled high blood pressure.
Patients who have severe liver disease.
Patients who have severe kidney disease.
Patients who are allergic to the study medications or their ingredients.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany
University Medicine Greifswald	Greifswald	Germany

Other Sites

Site Name	City	Country
Johannes Wesling Klinikum Minden	Minden	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Mcvsycftjoitfdbbwveayhyapw Hrfdpxvhuivsnveh	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	05.07.2022

Trial locations

Investigated drugs:

Fedratinib is a medication used in this trial to help treat myelofibrosis, a type of bone marrow cancer. It works by blocking certain proteins that are involved in the growth of cancer cells. This can help slow down or stop the progression of the disease, potentially improving symptoms and quality of life for patients who have not responded well to other treatments.

Nivolumab is another medication used in the trial, which is a type of immunotherapy. It helps the body’s immune system recognize and attack cancer cells more effectively. By enhancing the immune response, Nivolumab can help control the growth of cancer and may lead to better outcomes for patients with myelofibrosis who have not had success with other treatments.

Investigated diseases:

Primary Myelofibrosis – Primary Myelofibrosis is a chronic disorder where the bone marrow is gradually replaced by fibrous tissue, leading to a decrease in blood cell production. This condition often begins with an overproduction of blood cells, but as fibrosis progresses, it results in anemia, fatigue, and an enlarged spleen. Patients may experience symptoms such as night sweats, weight loss, and bone pain. Over time, the disease can lead to severe anemia and increased risk of bleeding or infections due to low blood cell counts. The progression of fibrosis in the bone marrow is a key feature of this disease.

Secondary Myelofibrosis – Secondary Myelofibrosis develops as a complication of other bone marrow disorders, such as Polycythemia Vera or Essential Thrombocythemia. It is characterized by the replacement of bone marrow with fibrous tissue, leading to reduced blood cell production. Symptoms include fatigue, anemia, and an enlarged spleen, similar to primary myelofibrosis. As the disease progresses, patients may experience increased symptoms due to low blood cell counts, such as weakness and susceptibility to infections. The condition is marked by the gradual worsening of bone marrow fibrosis.

Trial ID:

2024-513953-64-00

Protocol code:

FRACTION_2021

NCT ID:

NCT05393674

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Fedratinib and Nivolumab for Patients with Myelofibrosis Resistant to JAK-inhibitor Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?