Study of TP-3654 and Momelotinib 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 investigating the effects of a new treatment called TP-3654, which is taken as a capsule. Additionally, the study is exploring the combination of TP-3654 with another medication called momelotinib, which is taken as a tablet. The purpose of the study is to determine the safety and effectiveness of these treatments in patients with intermediate or high-risk primary or secondary myelofibrosis.

Participants in the study will receive either TP-3654 alone or in combination with momelotinib. The study will be conducted in two phases. In the first phase, researchers will determine the appropriate dose of TP-3654, both as a standalone treatment and in combination with momelotinib. In the second phase, the study will assess the preliminary effects of these treatments on the disease. Throughout the study, participants will be monitored for any side effects and changes in their condition.

The study aims to provide valuable information on how these treatments can help manage myelofibrosis. Participants will take the medications orally and will be regularly assessed to track their response to the treatment. The study will also evaluate changes in symptoms and overall health status to understand the potential benefits of TP-3654 and its combination with momelotinib for patients with myelofibrosis.

1 Joining the study

Upon joining the study, the patient will be assigned to one of the study arms. The study involves two main arms: TP-3654 Monotherapy and TP-3654 + Momelotinib Combination.

The patient will be required to provide informed consent, confirming understanding and agreement to comply with the study requirements.

2 Phase 1: Dose Escalation

In this phase, the patient will receive TP-3654 orally. The form of the medication may be a capsule or tablet.

The goal is to identify the recommended dose for Phase 2 by gradually increasing the dose while monitoring for any side effects.

3 Phase 1: Safety Assessment

The patient’s health will be closely monitored to assess the safety of TP-3654 or the combination of TP-3654 + Momelotinib.

This includes regular check-ups and tests to observe any adverse effects.

4 Phase 2: Clinical Activity Assessment

The patient will continue to receive the medication at the recommended dose identified in Phase 1.

The focus will be on evaluating the effectiveness of the treatment in reducing symptoms and improving health outcomes.

5 Medication Administration

The patient will take TP-3654 orally, either as a capsule or tablet, as prescribed by the study protocol.

If assigned to the combination arm, the patient will also take Momelotinib orally.

6 Regular Monitoring

Throughout the study, the patient will undergo regular monitoring, including blood tests and imaging, to track the response to the treatment.

The patient’s symptoms and overall health will be evaluated periodically to ensure safety and effectiveness.

7 Completion of Study Participation

Upon completion of the study, the patient will have a final evaluation to assess the overall impact of the treatment.

The study is estimated to conclude by April 2030, with individual participation duration varying based on the study arm and response to treatment.

Who Can Join the Study?

Must be an adult, which means 18 years of age or older.
Must have a confirmed diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera (PV)-MF/post-essential thrombocythemia (ET)-MF, which are specific types of blood disorders.
Must have intermediate or high-risk primary or secondary myelofibrosis, as determined by a specific scoring system called the Dynamic International Prognostic Scoring System (DIPSS).
Must have been previously treated with a JAK inhibitor, which is a type of medication, and either did not tolerate it, it did not work, or they are not eligible for it.
Must have a condition called splenomegaly, which means the spleen is enlarged, measured as at least 5 cm below the rib cage or a certain volume by imaging tests.
Must be able to swallow medication that is taken by mouth.
Must have a life expectancy of at least 6 months.
Must have a performance status of 1 or less, which means they are fully active or have some symptoms but can still do light work.
Must have adequate kidney function, shown by specific blood test results.
Must have adequate liver function, shown by specific blood test results.
Must have adequate blood clotting function, shown by specific blood test results.
Must be able to provide signed informed consent, which means they understand the study and agree to participate.
Must be non-fertile or agree to use a reliable method of birth control.
Must have at least two symptoms related to their condition that can be measured and scored.
For Arm 3, must have been previously treated with a JAK inhibitor (except momelotinib) for at least 12 weeks, or at least 4 weeks if there were complications like needing blood transfusions or severe side effects.
For Arm 3, must have anemia, which means low levels of hemoglobin in the blood, and meet other specific blood test criteria.
For Arm 3, must have at least two symptoms with a certain severity score or a total average score based on a specific assessment tool.

Who Cannot Join the Study?

Patients who have a different medical condition than the one being studied, which is Intermediate or High-risk Primary or Secondary Myelofibrosis.
Patients who are not within the specified age range for the study.
Patients who are not part of the clinical trial group being studied.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Medical University Of Graz	Graz	Austria
University Hospital Maastricht	Maastricht	The Netherlands
Institut Gustave Roussy	Villejuif	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
University Of Debrecen	Debrecen	Hungary
Fakultni Nemocnice Brno	Brno	Czechia
Region Midtjylland	Aarhus	Denmark
Onco Card S.R.L.	Brasov	Romania
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Universita Degli Studi Di Brescia	Brescia	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
ZNA Stuivenberg	Antwerp	Belgium
Ivdarobg Rzimtlmgq Pgf La Sennqq Dki Tfkhyg Drrw Anjxepu Iyce Szlpwl	Meldola	Italy
Mayhzikevcgnwfzmsvhqiitvec Hqryvpqteqdveaoc	Halle (Saale)	Germany
Dbn Prmaim Gazpssdn Ashnzjktmq Foe Inbwbtjckx Ptlginri Fim Mzonclc Awi Fqa Cggxaoud Hbbrprmxuh Eofn	Plovdiv	Bulgaria
Acmusyhtvf Ptvzrkwy Hgwbozlz Dz Pzfvg	Paris	France
Azlqcwz Oxcrvukwlue Ubhxiyqvvvpcs Cwppdjiouxtg Dlmzk Srxnzl E Dttgq Sgyisds Dc Tdxmpo	Turin	Italy
Admzqcw Otzmgnoclgy Nolotczxk Sw Atmcrwg E Bvlken E C Aewohc Ahffnsdfqlh	Alexandria	Italy
Ayohril Uprnw Stvadqsxi Lxffrb Dm Bnuyvou	Bologna	Italy
Idhqweoc Cxxboo Dqhzhyiclecsvxbhy	L'hospitalet De Llobregat	Spain
Cnknhu Hgwxcdgigcq Rjxmhgvg Dvqkhgnptvqvnb	Angers	France

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	15.06.2023
Belgium	Recruiting	15.06.2023
Bulgaria	Not yet recruiting	15.06.2023
Czechia	Not yet recruiting	15.06.2023
Denmark	Not yet recruiting	15.06.2023
France	Recruiting	15.06.2023
Germany	Not yet recruiting	15.06.2023
Hungary	Not yet recruiting	15.06.2023
Italy	Recruiting	15.06.2023
Poland	Not yet recruiting	15.06.2023
Romania	Not yet recruiting	15.06.2023
Spain	Recruiting	15.06.2023
The Netherlands	Not yet recruiting	15.06.2023

Trial locations

Investigated drugs:

Momelotinib Dihydrochloride Monohydrate

TP-3654 is an investigational medication being studied for its potential use in treating patients with intermediate or high-risk primary or secondary myelofibrosis. The study aims to determine the appropriate dosage for future phases and to evaluate the safety and initial effectiveness of this medication when used alone.

Momelotinib is a medication that is being tested in combination with TP-3654. The goal is to find the right dosage for the combination and to assess the safety and preliminary effectiveness of using both medications together in treating myelofibrosis.

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder characterized by the replacement of bone marrow with fibrous tissue, leading to a decrease in the production of blood cells. This condition can be primary, occurring on its own, or secondary, developing as a result of another bone marrow disorder. As the disease progresses, patients may experience symptoms such as fatigue, weakness, and an enlarged spleen. The reduction in blood cell production can lead to anemia, increased risk of infections, and bleeding issues. Over time, myelofibrosis can cause significant discomfort and impact daily life due to its chronic nature.

Trial ID:

2022-502597-16-00

Protocol code:

BBI-TP-3654-102

NCT ID:

NCT04176198

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of TP-3654 and Momelotinib for Patients with Intermediate or High-risk Myelofibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?