Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Not recruitingRare disease
Study on the Effects of Navitoclax and Ruxolitinib for Patients with Myelofibrosis
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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 a condition called Myelofibrosis, which is a type of blood cancer that affects the bone marrow. The study is testing a treatment using a medication called Navitoclax, either by itself or in combination with another medication called Ruxolitinib. Navitoclax is a type of drug known as a BCL-2 family protein inhibitor, which means it works by blocking certain proteins that help cancer cells survive. Ruxolitinib is a Janus Associated Kinases (JAKs) inhibitor, which helps reduce inflammation and control the growth of cancer cells.
The purpose of this study is to evaluate how well Navitoclax, alone or with Ruxolitinib, can reduce the size of the spleen in patients with Myelofibrosis. The study will observe participants over a period of time to see how their spleen size changes and to monitor any side effects they might experience. Participants will take the medication in tablet form, and the study will involve regular check-ups to assess their health and the effectiveness of the treatment.
Throughout the study, participants will be monitored for changes in their symptoms and overall health. The study aims to see if there is a significant reduction in spleen size and improvement in symptoms, such as fatigue and discomfort. The trial will also look at other factors like anemia response and changes in bone marrow condition. This research hopes to provide valuable information on the potential benefits of Navitoclax and Ruxolitinib for people living with Myelofibrosis.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Participants must be 18 years or older.
- For certain groups (Cohorts 1b and 3), participants must have at least 2 symptoms with a score of 3 or more, or a total score of 12 or more on a symptom assessment over 4 out of 7 days before starting the study medication.
- Participants must have splenomegaly, which means an enlarged spleen. This is defined as the spleen being 5 cm or more below the rib cage or having a spleen volume of 450 cm³ or more as measured by MRI or CT scan.
- Participants must have adequate bone marrow, kidney, and liver function as specified in the study protocol.
- Participants must have a confirmed diagnosis of Intermediate or High-risk Myelofibrosis, which includes different types like primary myelofibrosis, post-polycythemia vera myelofibrosis, or postessential thrombocythemia myelofibrosis.
- Participants must be classified as intermediate-2 or high-risk myelofibrosis according to a scoring system called the Dynamic International Prognostic Scoring System (DIPSS).
- Participants must be unable or unwilling to undergo a stem cell transplant due to age, other health conditions, or personal choice.
- Participants must have an ECOG performance status of 0, 1, or 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
- For Cohort 1a, participants must have been on ruxolitinib therapy for at least 12 weeks and on a stable dose of 10 mg or more twice daily for at least 8 weeks before the first dose of the study drug, navitoclax.
- For Cohort 1b, participants must have been treated with ruxolitinib for 24 weeks or more with no improvement, or for less than 24 weeks with disease progression, or for 28 days or more with intolerance, which means needing new red blood cell transfusions.
- For Cohort 2, participants must have had prior treatment with a JAK-2 inhibitor for at least 12 weeks, or for 28 days or more if it led to needing red blood cell transfusions or severe side effects like low platelet count, anemia, bruising, or bleeding.
- For Cohort 3, participants must not have had previous treatment with a JAK-2 or BET inhibitor.
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Verified sites
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Responsive Verified Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, ItalyVerified Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, Italy
Trial locations
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Investigated drugs
Navitoclax
is a medication being studied for its ability to reduce spleen size in patients with myelofibrosis. It works by targeting certain proteins in the body that help cancer cells survive, potentially leading to the death of these cells.
Ruxolitinib
is another medication used in this study, often in combination with Navitoclax. It is already used to treat myelofibrosis and works by blocking certain enzymes that contribute to the disease, helping to reduce symptoms and spleen size.
What is already known about the treatment
Navitoclax
Navitoclax is administered orally and is currently being studied in clinical trials for its effectiveness in treating myelofibrosis, a type of bone marrow disorder. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for navitoclax is to reduce spleen volume in patients with myelofibrosis. At the molecular level, navitoclax works by inhibiting proteins that prevent cell death, thereby promoting the death of cancerous cells. It is classified as a BCL-2 family protein inhibitor.
Ruxolitinib
Ruxolitinib is also administered orally and is being evaluated in combination with navitoclax for the treatment of myelofibrosis. It is already approved for use in certain conditions, including myelofibrosis, and is well-documented in medical literature. The primary therapeutic use of ruxolitinib is to manage symptoms and reduce spleen size in myelofibrosis patients. It works by inhibiting Janus kinases (JAK1 and JAK2), which are enzymes involved in the signaling pathways that control blood cell production and immune function. Ruxolitinib is classified as a JAK inhibitor.
Investigated diseases
Myelofibrosis – Myelofibrosis is a rare bone marrow disorder where the marrow is replaced by fibrous tissue, leading to a decrease in the production of blood cells. This condition often results in an enlarged spleen and can cause symptoms such as fatigue, weakness, and anemia. Over time, the fibrous tissue can disrupt normal blood cell production, leading to a variety of complications. Patients may experience a range of symptoms, including night sweats, fever, and weight loss. The disease can progress slowly or rapidly, varying significantly from person to person.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507276-53-00Protocol codeM16-109Estimated enrolment191 patientsSponsorAbbVie Deutschland GmbH & Co. KG
sourced from the EU Clinical Trials Register and site verification
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