Study on the Safety and Effects of Navitoclax and Ruxolitinib for Patients with Myelofibrosis and Myeloproliferative Neoplasms

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What is this study about?

This clinical trial is focused on studying the safety and effects of a medication called Navitoclax, both on its own and in combination with another medication called Ruxolitinib. The study is aimed at individuals with a group of diseases known as Myeloproliferative Neoplasms, which include conditions like Myelofibrosis. These diseases involve the abnormal growth of blood cells in the bone marrow. The trial also examines how Navitoclax affects the body when taken with Celecoxib, a medication often used for pain and inflammation.

The purpose of the study is to evaluate the safety, tolerability, and how the body processes these medications. Participants will receive the medications in different combinations and doses, and their health will be monitored closely. The study will also look at how Navitoclax affects the heart’s electrical activity, which is measured by a test called an ECG (electrocardiogram). This is important to ensure that the medications do not cause any harmful effects on the heart.

Throughout the study, participants will undergo regular health checks, including physical exams and laboratory tests, to monitor their response to the treatment. The study aims to gather information on the potential benefits and any side effects of the medications, helping to improve treatment options for people with Myeloproliferative Neoplasms.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Laboratory tests are performed to ensure adequate bone marrow reserves, platelet count, and other necessary health parameters.

2 treatment initiation

The treatment phase begins with the administration of navitoclax and ruxolitinib. These medications are taken orally in tablet form.

The dosage of ruxolitinib starts with 5 mg tablets, which may be adjusted to 10 mg tablets based on the response and tolerance.

3 combination therapy

In some parts of the study, navitoclax is administered alone, while in others, it is combined with ruxolitinib to evaluate the combined effect.

The combination aims to assess safety, tolerability, and the effect on specific health markers.

4 monitoring and evaluation

Regular monitoring is conducted to evaluate the safety and effectiveness of the treatment. This includes physical examinations, vital sign measurements, and laboratory tests.

Electrocardiograms (ECGs) are performed to monitor heart function, focusing on the QTc interval, which is a measure of the heart’s electrical cycle.

5 celecoxib interaction study

In a specific part of the study, the interaction between navitoclax and celecoxib is evaluated. Celecoxib is administered as a single dose to assess its pharmacokinetics when combined with navitoclax.

This phase helps understand how navitoclax affects the metabolism of celecoxib.

6 continuation and follow-up

Participants who benefit from the treatment may continue receiving navitoclax under specific conditions, especially in regions like France and Bulgaria.

Ongoing assessments ensure that the treatment remains beneficial and safe for continued use.

Who Can Join the Study?

Must be 18 years old or older.
Must have a documented diagnosis of certain blood disorders like primary or secondary Myelofibrosis (MF), Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Chronic Myelomonocytic Leukemia (CMML), as defined by the World Health Organization (WHO).
Must require treatment and have either failed or cannot tolerate at least one previous therapy. Also, must not be eligible for a type of treatment called allogeneic stem cell transplantation. If refusing standard therapy, enrollment is allowed only where local regulations permit.
Must have an ECOG performance status of 2 or less. This is a scale used to assess how a disease affects a patient’s daily living abilities, with lower numbers indicating better functioning.
Must meet specific laboratory requirements for blood and organ function, including bone marrow reserves, platelet count, neutrophil count, kidney and liver function, and certain enzymes and minerals in the blood.
For Part 3, must have a QTc interval of 450 milliseconds or less. This is a measure of heart rhythm on an electrocardiogram (ECG).
For Part 5, must have a documented diagnosis of primary MF, post-PV MF, or post-ET MF, and must either have no prior treatment with a JAK2 inhibitor or have received treatment with ruxolitinib under specific conditions.
For Part 6, must currently be receiving navitoclax in France or Bulgaria in a specific clinical trial and, in the opinion of the treating doctor, benefiting from the treatment.
For Part 6, must have completed assessments through the End of Treatment Visit or Treatment Completion Visit in their original study before starting navitoclax under Extension Part 6.

Who Cannot Join the Study?

Patients who have a different medical condition than the ones being studied, such as Myelofibrosis or Myeloproliferative Neoplasms, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the specific health requirements set by the study cannot participate.
Patients who are taking medications that might interfere with the study drugs cannot participate.
Patients who have a history of certain medical conditions that could affect the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Centre Antoine Lacassagne	Nice	France
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Klinikum Kassel GmbH	Kassel	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Universita Degli Studi Di Brescia	Brescia	Italy
Iaxlydsp Clobdi Dgmviuqmvouwblczx	L'hospitalet De Llobregat	Spain
Aozfeduuey Pbqwztlk Hyrfbsqs Dq Psljt	Paris	France
Ctqcsv Hahjkuhiebr Rtugnxxc Dedgobnhoflhli	Angers	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	22.04.2021
Croatia	Not recruiting	22.04.2021
France	Not recruiting	22.04.2021
Germany	Not recruiting	22.04.2021
Italy	Not recruiting	22.04.2021
Spain	Not recruiting	22.04.2021

Trial locations

Investigated drugs:

Navitoclax is a medication being studied for its safety and how well it is tolerated by patients with certain blood disorders, such as myeloproliferative neoplasms (MPN) and chronic myelomonocytic leukemia (CMML). It is being tested both on its own and in combination with another medication. The study also looks at how Navitoclax affects the heart’s electrical activity and how it interacts with other drugs.

Ruxolitinib is another medication involved in this study. It is used in combination with Navitoclax to see if the two drugs together can be more effective in treating myeloproliferative neoplasms. The study aims to understand how the combination affects patients and how the body processes these medications.

Celecoxib is a medication included in the study to see how Navitoclax affects its processing in the body. Celecoxib is typically used to relieve pain and inflammation, and the study is examining how safe and tolerable it is when taken with Navitoclax.

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.

Myeloproliferative Neoplasms – Myeloproliferative neoplasms are a group of diseases where the bone marrow makes too many red blood cells, white blood cells, or platelets. These conditions can lead to various symptoms, including fatigue, headaches, and an increased risk of bleeding or clotting. The excess cells can cause the blood to thicken, slowing its flow and potentially leading to complications. Over time, these neoplasms can progress to more severe forms, such as acute leukemia. The disease’s progression varies depending on the specific type of myeloproliferative neoplasm.

Chronic Myelomonocytic Leukemia – Chronic myelomonocytic leukemia (CMML) is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. It is characterized by an increased number of monocytes, a type of white blood cell, in the blood. Patients may experience symptoms such as fatigue, fever, and weight loss. As CMML progresses, it can lead to anemia, infections, and bleeding problems due to the disruption of normal blood cell production. The disease can transform into acute myeloid leukemia, a more aggressive form of leukemia.

Trial ID:

2023-507274-40-00

Protocol code:

M19-753

NCT ID:

NCT04041050

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Navitoclax and Ruxolitinib for Patients with Myelofibrosis and Myeloproliferative Neoplasms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?