Study of BMS-986158 Alone and with Ruxolitinib or Fedratinib for Patients with Intermediate or High Risk Myelofibrosis

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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 specifically looking at patients with intermediate or high risk of this disease. The trial will test a new treatment approach using a medication known as BMS-986158, both on its own and in combination with other medications called Ruxolitinib and Fedratinib. These medications are taken orally, meaning they are swallowed in the form of tablets or capsules.

The purpose of the study is to assess the safety and tolerability of these treatments. The study will be conducted in two parts. In the first part, the focus will be on finding the right dose of BMS-986158 when used with Ruxolitinib or Fedratinib. In the second part, the study will further explore the safety of these combinations and also test BMS-986158 as a standalone treatment. Participants will be monitored for any side effects and how well they tolerate the medications.

Throughout the study, participants will undergo regular assessments, including imaging tests like MRI or computed tomography (CT) scans, to measure changes in their condition. The study aims to provide valuable information on how these treatments can be used to manage myelofibrosis, potentially offering new options for patients with this challenging disease.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A series of tests, such as blood tests and imaging scans, will be performed to assess the current health status and the size of the spleen.

2 treatment allocation

Participants will be assigned to one of the treatment groups. The treatment may involve BMS-986158 alone or in combination with either ruxolitinib or fedratinib.

The specific treatment plan will depend on previous exposure to certain medications and the current health condition.

3 medication administration

The medications will be administered orally in the form of tablets or capsules.

The dosage and frequency will be determined by the study protocol and may vary depending on the treatment group.

4 regular monitoring

Regular visits to the study site will be required for monitoring. This includes physical examinations, blood tests, and imaging scans to assess the response to treatment.

Participants will be monitored for any side effects or adverse reactions to the medication.

5 dose adjustment

Based on the response to treatment and any side effects experienced, the dosage of the medication may be adjusted.

The study team will provide guidance on any changes to the treatment plan.

6 end of treatment evaluation

At the end of the treatment period, a final evaluation will be conducted. This includes a comprehensive assessment of health status and the effectiveness of the treatment.

Participants will be informed about the results and any further steps that may be necessary.

Who Can Join the Study?

Must be a male or female who is at least 18 years old.
Must have a diagnosis of Myelofibrosis (MF), which is a type of blood cancer, according to specific medical criteria.
Must have a DIPSS Risk Score of Intermediate-1 with symptoms, Intermediate-2, or High. DIPSS is a system used to determine the risk level of the disease.
Must have a measurable enlarged spleen during the screening period, as shown by a specific type of scan (MRI or CT scan).
Must have an ECOG Performance Status of 2 or less. This is a scale used to assess how the disease affects daily living abilities, with lower numbers indicating better function.
For certain parts of the study, must not have been treated with JAK2 inhibitors before starting the study treatment. JAK2 inhibitors are a type of medication used to treat MF.
For other parts of the study, must have been treated with ruxolitinib (a JAK2 inhibitor) for at least 3 to 6 months and have a sub-optimal response, meaning the treatment did not work as well as expected.
For some study groups, must have been previously treated with ruxolitinib and meet specific criteria related to treatment response or side effects.
Must not be a candidate for, or must have refused, allogenic stem cell transplant (SCT), which is a procedure that replaces damaged bone marrow with healthy cells.

Who Cannot Join the Study?

Patients with any other serious medical condition that might affect their ability to participate in the study.
Patients who have had another type of cancer within the last 3 years, except for certain skin cancers or cervical cancer that has been treated.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
Patients who have had a major surgery within the last 4 weeks.
Patients who have a known allergy to any of the study drugs or their ingredients.
Patients who have received another investigational drug within the last 4 weeks.
Patients who have a history of certain heart problems, such as a heart attack or heart failure.
Patients who have uncontrolled high blood pressure.
Patients who have a history of bleeding disorders or are taking blood thinners that cannot be stopped.
Patients who have a history of drug or alcohol abuse within the last 2 years.
Patients who have a mental health condition that might affect their ability to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Onkologie Erding	Erding	Germany

Other Sites

Site Name	City	Country
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Centre Hospitalier Universitaire De Nice	Nice	France
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Metuivcmmcgsjuilelcgblpvea Hgjjxepslnukkonq	Halle (Saale)	Germany
Hnqcutkr Ufedrwskkyhuc Mnwflut Dj Vhckejwsky	Santander	Spain
Aiwleviofm Ponzaprr Htxlmwec Di Peych	Paris	France
Uwomnmvgpcjzbj Cawsqky Koukmywdp	Gdansk	Poland
Hkkffien Uzkgqwbqmtjrp Hkchnkov Tmtyf y Prasbh Iasxjkhy Csrpmp deffpwhbgibeeytfb (rtkl	Badalona	Spain
Itvedkvr Pbfgnbzmwkzyckf Cxqofe Clkfgb	Marseille	France
Usnxkxorsa Gsakapm Hnwcyqhk Asxskvi	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	22.03.2021
Germany	Not recruiting	22.03.2021
Greece	Not recruiting	22.03.2021
Italy	Not recruiting	22.03.2021
Poland	Not recruiting	22.03.2021
Romania	Not recruiting	22.03.2021
Spain	Not recruiting	22.03.2021

Trial locations

Investigated drugs:

BMS-986158 is an experimental medication being tested to see how safe and tolerable it is for people with a condition called myelofibrosis, which affects the bone marrow. This medication is being studied both on its own and in combination with other treatments to find the best dose that can be used safely.

Ruxolitinib is a medication that is already used to treat myelofibrosis. It works by blocking certain proteins in the body that can cause inflammation and other symptoms of the disease. In this trial, it is being combined with BMS-986158 to see if the combination is more effective for patients who have not been treated before.

Fedratinib is another medication used to treat myelofibrosis, especially in patients who have already been treated with ruxolitinib. It also works by targeting specific proteins involved in the disease. In this study, it is being tested in combination with BMS-986158 to see if it can help patients who have already tried other treatments.

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 due to the lack of healthy blood cells. The disease can evolve slowly, with symptoms worsening gradually over several years.

Trial ID:

2023-509635-89-00

Protocol code:

CA011-023

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of BMS-986158 Alone and with Ruxolitinib or Fedratinib for Patients with Intermediate or High Risk Myelofibrosis

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