All studies
Active not recruitingPHASE2INTERVENTIONAL

Extended Access of Momelotinib in Adults With Myelofibrosis

This study is designed for adults with a type of bone marrow disorder called myelofibrosis (including primary myelofibrosis, or after polycythemia vera or essential thrombocythemia). It's an opportunity for people who are already taking a medication called momelotinib in certain previous studies and are doing well on it to continue their treatment. The main goal is to keep an eye on how safe momelotinib is over a longer period. Researchers will also look at how it might affect how long people live and whether it helps prevent the illness from turning into leukaemia. This helps ensure patients who are benefiting can continue their current care.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
237
Start
03 May 2018
Estimated completion
11 Dec 2026

What is this study about?

This research study is about a medicine called momelotinib. It's particularly for adults who have a bone marrow condition known as myelofibrosis. Myelofibrosis causes scar tissue to build up in the bone marrow, which can affect the body's ability to make healthy blood cells.

The main purpose of this study is to allow people who are already taking momelotinib in other ongoing studies to continue receiving the treatment. This is important because it means patients who are finding the medication helpful can keep taking it, rather than having to stop. The medical team will carefully watch to see if momelotinib continues to be safe for them over a longer time.

Beyond safety, the study will also look at how momelotinib affects people’s overall health and how long they live. Researchers will also be checking if it helps reduce the risk of myelofibrosis progressing to leukaemia, which is a more serious type of blood cancer. This helps us understand the long-term benefits of the treatment.

Key takeaways

  • This study is an extension for people already on momelotinib for myelofibrosis.
  • It aims to check the long-term safety of momelotinib.
  • Researchers will also look at overall survival and leukaemia-free survival.
  • You must be an adult already taking part in a specific momelotinib study.
  • You cannot join if you are allergic to momelotinib.

Who may be eligible?

This study is for adults who are already taking part in specific previous research studies involving momelotinib. You must be currently receiving momelotinib treatment in one of these studies and it must be helping you, meaning your illness hasn't gotten worse while on the medication.

To be considered, you need to be able to understand what the study involves and be willing to sign a consent form, which shows you agree to take part. You must be at least 18 years old.

Hover, you cannot join this study if you've had a bad reaction or are very sensitive to momelotinib or any of its ingredients in the past. Your doctor or the study team will be able to check all the specific details to see if this study is right for you.

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.

  1. Are you currently taking momelotinib in one of the specific previous studies?
  2. Is momelotinib currently helping your myelofibrosis, meaning your disease hasn't gotten worse?
  3. Are you 18 years old or older?
  4. Have you ever had a severe allergic reaction to momelotinib or any of its ingredients?
Answer every question to see your result.

What does participation involve?

As this an extension study, if you are eligible, you would continue to take momelotinib medication, which comes in tablet form (50mg, 100mg, 150mg, or 200mg strengths). The frequency of your visits to the clinic will be determined by the study team to monitor your health and the effects of the medication. These visits will involve various tests and check-ups to assess your safety and how well the treatment is working. The total duration for how long you will participate in this extended access program will depend on your individual response to the treatment and the study's overall plan.

Potential risks and benefits

Taking part in this study means you can continue to receive momelotinib if it's helping you manage your myelofibrosis. This could lead to ongoing improvement in your symptoms or help slow the progression of your condition. However, like all medicines, momelotinib can have side effects, and these will be carefully monitored by the study team. You will be told about any known risks before you agree to participate. Remember, taking part in any study is completely voluntary, and you have the right to withdraw at any time without explaining why, and this will not affect your future medical care.

Locations (112)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Scottsdale, United States
  • GSK Investigational Site
    Verified postcode
    Orange, United States
  • GSK Investigational Site
    Verified postcode
    Stanford, United States
  • GSK Investigational Site
    Verified postcode
    Aurora, United States
  • GSK Investigational Site
    Verified postcode
    Jacksonville, United States
  • GSK Investigational Site
    Verified postcode
    Tampa, United States
  • GSK Investigational Site
    Verified postcode
    Atlanta, United States
  • GSK Investigational Site
    Verified postcode
    Baltimore, United States
  • GSK Investigational Site
    Verified postcode
    Boston, United States
  • GSK Investigational Site
    Verified postcode
    Rochester, United States
  • GSK Investigational Site
    Verified postcode
    St Louis, United States
  • GSK Investigational Site
    Verified postcode
    Hackensack, United States

Common questions

What is myelofibrosis?

Myelofibrosis is a condition where scar tissue builds up in your bone marrow, affecting its ability to make healthy blood cells.

What is momelotinib?

Momelotinib is a medication being studied for its effects on myelofibrosis. It comes in different strength tablets.

Who can join this study?

This study is mainly for adults who are already taking momelotinib in specific previous studies and are doing well on the treatment.

What happens if I join?

You would continue taking momelotinib, and the study team would regularly check your health and how the medicine is affecting you.

Can I stop taking part in the study?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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