Study of TL-895 for Patients with Relapsed or Refractory Myelofibrosis or Indolent Systemic Mastocytosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called TL-895 in individuals with certain blood-related conditions. The diseases being studied are Myelofibrosis and Indolent Systemic Mastocytosis. Myelofibrosis is a disorder where scar tissue forms in the bone marrow, affecting blood cell production. Indolent Systemic Mastocytosis is a condition where there is an abnormal accumulation of mast cells, a type of white blood cell, in various tissues. The medication TL-895 is taken orally in the form of a film-coated tablet.

The purpose of this study is to determine the appropriate dose and schedule for TL-895 in treating these conditions. Participants in the study will receive either the medication or a placebo. The study will be conducted over a period of time, during which participants will be monitored for changes in their symptoms and overall health. The study aims to find out if TL-895 can improve symptoms and reduce the size of the spleen in patients with Myelofibrosis, as well as assess changes in symptoms for those with Indolent Systemic Mastocytosis.

Throughout the study, participants will be regularly assessed to ensure their safety and to evaluate the effectiveness of the treatment. The study will help determine if TL-895 is a viable treatment option for these conditions and will provide valuable information on how best to use the medication in future treatments. The trial is expected to conclude by the end of 2025.

1 joining the study

Upon joining the study, participation is confirmed based on specific criteria related to age, diagnosis, and health status.

Eligibility is determined by a confirmed diagnosis of either myelofibrosis or indolent systemic mastocytosis.

2 initial assessment

An initial assessment is conducted to evaluate symptoms and overall health.

This includes a review of medical history and current symptoms.

3 medication administration

The medication TL-895 is administered in the form of a film-coated tablet.

The route of administration is oral, meaning the tablet is taken by mouth.

4 dose determination

The study aims to determine the recommended phase 2 dose and schedule of TL-895.

This involves monitoring the effects of the medication over time.

5 symptom monitoring

Symptoms are monitored regularly to assess any changes or improvements.

This includes tracking the Total Symptom Score at specific intervals, such as at week 24.

6 end of study

The study is estimated to conclude by December 31, 2025.

Final assessments are conducted to evaluate the overall impact of the treatment.

Who Can Join the Study?

For Cohorts 1-3: You must be an adult aged 18 years or older.
For Cohorts 1-3: You need a confirmed diagnosis of one of the following: Primary Myelofibrosis (PMF), post-Polycythemia Vera Myelofibrosis (post-PV MF), or post-Essential Thrombocythemia Myelofibrosis (post-ET MF). This diagnosis should be made by your doctor following the World Health Organization (WHO) criteria.
For Cohorts 1-3: You should have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that helps doctors understand how your disease affects your daily living abilities.
For Cohorts 1-3: You must have adequate blood, liver, and kidney functions.
For Cohorts 1-3: You should have symptoms of Myelofibrosis (MF) with at least 2 symptoms scoring an average of at least 1 on a specific symptom assessment form (MFSAF v4.0) during the week before starting the study.
For Cohort 3 only: You must be ineligible for JAK inhibitor treatment and have a platelet count between 25 and 50 x 10⁹/L. Platelets are cells in your blood that help with clotting.
For Cohort 5: You need a confirmed diagnosis of Indolent Systemic Mastocytosis (ISM) based on a review of your bone marrow biopsy pathology report results, following WHO diagnostic criteria.
For Cohort 5: You must have moderate-to-severe symptoms.

Who Cannot Join the Study?

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures.
Patients with certain types of infections that are not well controlled.
Patients with a history of substance abuse that might affect the study.
Patients who have had a recent major surgery.
Patients with certain heart conditions that are not stable.
Patients with severe liver or kidney problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oslo Universitetssykehus HF	Oslo	Norway
University Hospital Jena KöR	Jena	Germany
Technische Universitaet Dresden	Dresden	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Hospital Quironsalud Zaragoza	Zaragoza	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Azienda Ospedaliera di Padova	Padua	Italy
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Le Mans	Le Mans	France
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Universitaire De Nice	Nice	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Culwwrfxm Ukirylaqedmtka Smmrjkcla	Woluwe-Saint-Lambert	Belgium
Uyhfsbwexs Mbuthxf Cvcgur Hhclhksidxdigkbxx	Hamburg	Germany
Itevkyst Csiong Dpagnwmfooqnzimvs	L'hospitalet De Llobregat	Spain
Exqwmny Uhymjobleftj Mbxrnxw Cfwptku Rvbczgomr (lagtxvx Mtm	Rotterdam	The Netherlands
Azeyete Uvrob Stmugojfp Ltrluq Df Bwpwmgw	Bologna	Italy
Mivsdgqw Mzxhdwl Aofdsja	Pleven	Bulgaria
Ukmxrdpzqpgcjt Cqufuoo Kyiqohnju	Gdansk	Poland
Ukejrcfxcz Oq Aunophe	Edegem	Belgium
Usuznfctvh Dnpuh Sgdje Df Rzvs Lv Swwdhlhv	Rome	Italy
Mzjgcedhymrkjjhznqvlvbrjnf Huuwbcmzuwbtnpre	Halle (Saale)	Germany
Hehhutcl Umnmibuugpbqm Hzyltmtf Txklr y Ppmcfx Ipughduh Crfzwc ddzognmbcvgabbuwj (cbtp	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	30.10.2020
Bulgaria	Not recruiting	30.10.2020
France	Not recruiting	30.10.2020
Germany	Recruiting	30.10.2020
Italy	Recruiting	30.10.2020
Norway	Recruiting	30.10.2020
Poland	Not recruiting	30.10.2020
Spain	Recruiting	30.10.2020
The Netherlands	Recruiting	30.10.2020

Trial locations

Investigated drugs:

1-4-{[6-Amino-5-(4-Phenoxy-Phenyl)-Pyrimidin-4-Ylamino]-Methyl}-4-Fluoro-Piperidin-1-Yl)-Propenone

TL-895 is an investigational medication being studied for its potential use in treating certain types of myelofibrosis and indolent systemic mastocytosis. Myelofibrosis is a rare type of bone marrow cancer that disrupts the body’s normal production of blood cells. This medication is being tested in patients who have not responded well to other treatments or who cannot tolerate other medications. The study aims to find the best dose and schedule for using TL-895 to help improve symptoms in these patients.

Myelofibrosis – Myelofibrosis is a rare bone marrow disorder where the marrow is replaced by fibrous tissue, leading to a decrease in blood cell production. This condition often results in anemia, fatigue, and an enlarged spleen. Over time, the body’s ability to produce blood cells diminishes, causing various symptoms related to low blood counts. Patients may experience weakness, weight loss, and night sweats. The disease can progress slowly, but the symptoms can significantly impact daily life.

Indolent Systemic Mastocytosis – Indolent Systemic Mastocytosis is a condition characterized by an abnormal accumulation of mast cells in various tissues, including the skin, bone marrow, and internal organs. This accumulation can lead to symptoms such as skin rashes, itching, and abdominal discomfort. The disease is termed “indolent” because it progresses slowly and often has a stable course. Patients may experience episodes of flushing, low blood pressure, and gastrointestinal issues. Despite the chronic nature of the condition, it typically does not lead to organ damage.

Trial ID:

2024-514467-26-00

Protocol code:

TL-895-201

NCT ID:

NCT04655118

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of TL-895 for Patients with Relapsed or Refractory Myelofibrosis or Indolent Systemic Mastocytosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?