Study on Tasquinimod for Patients with Myelofibrosis Who Are Refractory or Intolerant to JAK2 Inhibitors

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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 testing a treatment called tasquinimod, which is taken as a capsule. Tasquinimod is being tested in different doses: 0.25 mg, 0.5 mg, and 1 mg. The purpose of the study is to see if tasquinimod is safe and effective for patients who have myelofibrosis and have not responded well to or cannot tolerate another type of treatment known as JAK inhibitors.

The study is divided into two phases. In the first phase, the focus is on determining the safety of tasquinimod and finding the right dose that can be used in the second phase. The second phase aims to evaluate how well tasquinimod works in reducing the size of the spleen, which is often enlarged in patients with myelofibrosis. This is measured using imaging techniques like MRI or CT scan after 24 weeks of treatment.

Participants in the study will take tasquinimod once daily and will be monitored for any side effects and changes in their condition. The study will also look at other outcomes, such as overall survival, changes in symptoms, and the need for blood transfusions. The trial is expected to continue until 2030, with recruitment starting in 2024.

1 joining the study

Upon joining the study, you will be asked to provide written consent, confirming your understanding and willingness to participate.

A negative pregnancy test is required for women who can become pregnant. Both women and men must agree to use effective birth control methods during the study and for a specified period after the study ends.

2 initial assessment

An initial assessment will be conducted to confirm your diagnosis of myelofibrosis. This may involve reviewing a bone marrow biopsy that is not older than six months.

Your ability to swallow and retain oral medication will be evaluated, and your overall health status will be assessed using a performance status scale.

3 medication administration

You will begin taking tasquinimod capsules orally once a day. The dosage will start at 0.25 mg and may be adjusted to 0.5 mg or 1 mg based on your response and tolerance.

The medication will be taken daily for the duration of the study, which is divided into two phases: Phase 1b and Phase 2.

4 phase 1b

During Phase 1b, the focus will be on assessing the safety and feasibility of the medication. The goal is to determine the appropriate dosage and identify any side effects.

Regular check-ups will be scheduled to monitor your health and any potential side effects of the medication.

5 phase 2

In Phase 2, the effectiveness of the medication will be evaluated. This involves measuring the reduction in spleen size using imaging techniques like MRI or CT scans after 24 weeks.

Your symptoms and overall health will continue to be monitored throughout this phase.

6 ongoing monitoring

Throughout the study, regular visits will be scheduled to assess your health, conduct laboratory tests, and ensure compliance with the treatment plan.

Your response to the medication, including any changes in symptoms or side effects, will be closely monitored.

Who Can Join the Study?

Diagnosis of Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF) based on a bone marrow test not older than 6 months.
Must have tried a JAK inhibitor treatment and found it ineffective or intolerable, or be ineligible for such treatment. A JAK inhibitor is a type of medication used to treat certain blood disorders.
Myelofibrosis classified as Intermediate-1 with disease-related symptoms (like an enlarged spleen), Intermediate-2, or high-risk according to a specific scoring system used by doctors.
Spleen is at least 5 cm below the rib cage as felt by a doctor.
Must be 18 years of age or older.
Peripheral blood blast count of less than 10%. This refers to the percentage of immature blood cells in the blood.
Performance status of 0, 1, or 2 on the WHO/ECOG scale, which measures how well a person can perform daily activities.
Able to swallow and keep down oral medication.
Willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests.
Negative pregnancy test at the start of the study for women who can have children.
Women who can have children and sexually active men must agree to use highly effective birth control methods during treatment and for 4 months (women) and 6 months (men) after treatment.
Capable of giving informed consent, meaning you understand the study and agree to participate.
Must provide written informed consent, which is a document that explains the study and confirms your agreement to participate.

Who Cannot Join the Study?

Patients who are not able to stop using other treatments that might interfere with the study drug.
Patients with severe heart problems that are not well controlled.
Patients with severe liver disease.
Patients with severe kidney disease.
Patients who have had another type of cancer in the last 5 years, except for skin cancer that is not melanoma.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that requires treatment with antibiotics.
Patients who have a known allergy to the study drug or its ingredients.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a history of drug or alcohol abuse within the last 2 years.

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
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Utvxnmwbythx Mrpkgdn Coycsmg Gavljedat	Groningen	The Netherlands
Agmtwrgtc Ulz	Amsterdam	The Netherlands
Eimiqxd Uichmmihrwsi Mwltxpg Caqmnow Rsybvdbab (dzenjpc Mtz	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	30.09.2024
The Netherlands	Not yet recruiting	30.09.2024

Trial locations

Investigated drugs:

Tasquinimod

Tasquinimod is a medication being studied for its potential to help patients with a type of blood cancer called myelofibrosis. Myelofibrosis can cause the bone marrow to produce too much fibrous tissue, which can lead to an enlarged spleen and other symptoms. This medication is being tested in patients who have not responded well to or cannot tolerate another type of treatment known as JAK inhibitors. The goal of the trial is to see if tasquinimod can safely reduce the size of the spleen and improve symptoms in these patients. The study is divided into two phases: the first phase focuses on determining the safety and appropriate dosage of the medication, while the second phase evaluates how effective it is in reducing spleen size after 24 weeks of treatment.

Investigated diseases:

Primary myelofibrosis

Myelofibrosis – Myelofibrosis is a disorder where scar tissue forms in the bone marrow, disrupting the body’s ability to produce blood cells. This condition leads to anemia, weakness, fatigue, and often an enlarged spleen. Over time, the bone marrow becomes increasingly fibrotic, reducing its capacity to generate blood cells. As the disease progresses, patients may experience severe anemia and increased risk of bleeding or infections. The spleen and liver may enlarge as they try to compensate for the bone marrow’s reduced function. Symptoms can vary widely among individuals, and the disease can progress at different rates.

Trial ID:

2024-511565-11-00

Protocol code:

HOVON 172 MF

NCT ID:

NCT06605586

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Tasquinimod for Patients with Myelofibrosis Who Are Refractory or Intolerant to JAK2 Inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?