Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib
This research is investigating a new medication called TL-895 for people with myelofibrosis, a condition where the bone marrow doesn't produce blood cells properly. We want to see how well it works, especially when combined with ruxolitinib, a treatment already used for myelofibrosis. The study is open to two groups of people: those who haven't started ruxolitinib yet, and those who are already taking ruxolitinib but aren't feeling as well as they hoped. Doctors will be checking to see if TL-895 helps manage key symptoms and improves overall well-being. This is an early-stage study, meaning we're learning about the drug's safety and how it works.
At a glance
What is this study about?
This study is about a new drug, TL-895, for a condition called myelofibrosis. Myelofibrosis is a rare type of bone marrow cancer where the bone marrow, which usually makes blood cells, becomes scarred. This can lead to various problems, including an enlarged spleen, tiredness, and anaemia.
Researchers want to see if TL-895, which is a tablet taken by mouth, can help people with myelofibrosis. They are particularly interested in two groups: those who haven't yet taken a common treatment for myelofibrosis called ruxolitinib, and those who are currently taking ruxolitinib but aren't getting the full benefit they need. The aim is to understand how TL-895 works, if it's safe, and if it can improve symptoms or overall health in people with myelofibrosis.
This study is in its early stages (Phase 1 and 2), which means it's one of the first times this drug is being tested more widely in people. This helps doctors learn a lot about new treatments before they become more widely available. It's a key step in finding better ways to manage myelofibrosis.
Key takeaways
- This study is testing a new drug for myelofibrosis.
- It's for people new to ruxolitinib or not getting enough benefit from it.
- The new drug, TL-895, is a tablet you take by mouth.
- Your health will be closely monitored with regular visits and tests.
- Participation is voluntary, and you can withdraw at any time.
- This is an early-stage study to learn about safety and effectiveness.
Who may be eligible?
To join this study, you need to be at least 18 years old and have been diagnosed with myelofibrosis. This includes different types like primary myelofibrosis, or myelofibrosis that developed after having other blood conditions like polycythaemia vera or essential thrombocythaemia.
If you're already taking ruxolitinib, you need to have been on a steady dose for a while, and your doctors must feel that it's not working as well as it could be. Your spleen should also be noticeably enlarged. We'll check your general health, including your blood, liver, and kidney function, to make sure you're well enough to take part.
You cannot join if you've had a spleen removal or spleen radiation in the past six months, or if you've already tried certain other newer medications. If you haven't taken ruxolitinib before, you also can't have had any other similar types of medication.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of myelofibrosis (any type)?
- Is your spleen enlarged (or has it been measured as large)?
- If you take ruxolitinib, is it not working as well as you'd hoped?
- Have you avoided spleen surgery or radiation in the last 6 months?
- Are you generally healthy enough for a clinical trial?
What does participation involve?
If you decide to take part, you'll be taking the study medication, TL-895, as tablets. If you're in the group already taking ruxolitinib, you'll continue with that medication alongside TL-895. You'll have regular visits to the clinic for check-ups, blood tests, and scans (like MRI or CT scans) to monitor your spleen and overall health. These visits will help the doctors understand how the medication is affecting you. The total length of your participation would be discussed in detail by the study team, but typically, these early-stage studies involve ongoing monitoring.
Potential risks and benefits
Locations (19)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- Gabrail Cancer CenterVerified postcodeCanton, United States· Recruiting
- University of Cincinnati (UC)Verified postcodeCincinnati, United States· Recruiting
- The University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States· Recruiting
- CHU AngersVerified postcodeAngers, France· Recruiting
- AP-HM - Hôpital de la TimoneVerified postcodeMarseille, France· Recruiting
- CHU de Nice - Hopital L'Archet IIVerified postcodeNice, France· Recruiting
- Hôpital Saint Louis - AP-HPVerified postcodeParis, France· Recruiting
- Centre Hospitalier Lyon SudVerified postcodePierre-Bénite, France· Recruiting
- Marien Hospital DuesseldorfVerified postcodeDüsseldorf, Germany· Recruiting
- Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum HallVerified postcodeHalle, Germany· Recruiting
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaVerified postcodeBologna, Italy· Recruiting
Common questions
What is myelofibrosis?
Myelofibrosis is a condition where your bone marrow, which makes blood cells, becomes scarred, leading to problems like an enlarged spleen and feeling very tired.
What is TL-895?
TL-895 is a new tablet medication being tested to see if it can help treat myelofibrosis by targeting specific pathways in the body.
What is ruxolitinib?
Ruxolitinib is a common medication already used to treat myelofibrosis.
Why is this study important?
This study helps doctors learn if TL-895 is a safe and effective new treatment option for myelofibrosis, especially for people who haven't tried ruxolitinib or aren't getting enough benefit from it.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
John Mei
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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