Active not recruitingPHASE3INTERVENTIONAL

Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

This study is for adults with myelofibrosis, a rare blood cancer where the bone marrow scars and the spleen can get bigger. We're testing a new drug called navitoclax. Participants will be randomly assigned to one of three groups: one group gets navitoclax with ruxolitinib, another gets only navitoclax, and the third gets the usual best treatment available. The aim is to see if the new treatments can help reduce spleen size and are safe, compared to standard care. This is a large study involving about 330 people across many countries. If you've had myelofibrosis that has come back or didn't get better with earlier treatment, you might be eligible.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

330

Start

31 Aug 2020

Estimated completion

01 Dec 2026

Myelofibrosis (MF)

What is this study about?

Myelofibrosis (MF) is a rare type of blood cancer where the spongy tissue inside your bones, called bone marrow, becomes scarred. This scarring can make it hard for your body to make healthy blood cells. Often, a common problem with MF is that your spleen – an organ that helps filter blood – can become enlarged.

This study is looking for better ways to treat MF, especially for adults whose current treatments haven't worked well or whose cancer has returned. We are investigating a new medicine called navitoclax. This drug is still being tested and hasn't been approved for general use yet. We want to see how well navitoclax works, both on its own and when combined with another common MF medicine called ruxolitinib. We'll compare these new approaches to the standard care usually given for MF.

The main goals of this study are to find out if navitoclax, either alone or with ruxolitinib, can help shrink an enlarged spleen and if these treatments are safe. We'll also be looking at how people feel and if these treatments improve their quality of life. About 330 adults with MF are expected to take part in this study across various locations worldwide.

Key takeaways

This study is for adults with myelofibrosis that hasn't responded to previous treatment.
It tests a new drug, navitoclax, alone or with ruxolitinib, against standard care.
The main goals are to check spleen size changes and safety.
Participants will be randomly assigned to one of three treatment groups.
Participation involves regular hospital visits, tests, and questionnaires.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with myelofibrosis. Crucially, your myelofibrosis must have either come back or not improved after you've already had at least one treatment with a specific type of medicine called a JAK2 inhibitor, like ruxolitinib. It doesn't matter if you stopped ruxolitinib or are still taking it.

You also need to be experiencing certain symptoms of myelofibrosis, like an enlarged spleen that can be felt or other troublesome symptoms. The study will assess these using a special questionnaire to make sure your symptoms are significant enough to be included. Your doctor will also check the specifics of your myelofibrosis diagnosis to make sure it matches the study criteria.

There are also specific medical and cancer-related assessments your doctor will complete to confirm your eligibility. These include checking the grade of scarring in your bone marrow and classifying the risk level of your myelofibrosis. There are certain health conditions or treatments that might mean you can't join the study, but your doctor can discuss these with 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.

Are you 18 years old or older?
Have you been diagnosed with myelofibrosis?
Has your myelofibrosis come back or not improved after previous treatment with a JAK2 inhibitor (like ruxolitinib)?
Are you experiencing symptoms related to your myelofibrosis, such as an enlarged spleen or other significant symptoms?
Are you able to regularly visit a hospital or clinic for appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of three treatment groups, like drawing names out of a hat. You, nor your doctor, will be able to choose which group you are in.

* **Group A** will take navitoclax tablets once a day and ruxolitinib tablets twice a day. * **Group B** will receive the best available treatment that your doctor would normally recommend for your condition. * **Group C** will take navitoclax tablets once a day.

You will continue your assigned treatment for approximately three years, or until your doctor decides the treatment is no longer helping, you can't tolerate it, or you choose to stop. Taking part means you will have regular visits to a hospital or clinic. During these visits, the study team will carry out medical checks, take blood and bone marrow samples, monitor you closely for any side effects, and ask you to fill out questionnaires about how you're feeling. This helps us understand how well the treatment is working and if it's safe.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. You might benefit from receiving a new treatment that could improve your symptoms or spleen size. However, there's no guarantee that the study treatments will help you, and you might experience side effects from the medicines. The study team will carefully monitor you for any side effects, but there might be more appointments and tests than your usual care. It's important to remember that participating in the study is completely voluntary, and you have the right to withdraw at any time for any reason without it affecting your future medical care.

Locations (229)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ironwood Cancer & Res Ctr /ID# 222162
Verified postcode
Chandler, United States
Highlands Oncology Group, PA /ID# 221826
Verified postcode
Springdale, United States
City of Hope /ID# 218996
Verified postcode
Duarte, United States
Providence - St. Jude Medical Center /ID# 271382
Verified postcode
Fullerton, United States
Moores Cancer Center /ID# 271596
Verified postcode
La Jolla, United States
Moores Cancer Center at UC San Diego /ID# 219009
Verified postcode
La Jolla, United States
Long Beach Memorial Medical Ct /ID# 224542
Verified postcode
Long Beach, United States
Icri /Id# 221967
Verified postcode
Whittier, United States
St. Mary's Hospital Regional Cancer Center /ID# 224229
Verified postcode
Grand Junction, United States
Augusta University Georgia Cancer Center /ID# 219051
Verified postcode
Augusta, United States
Columbus Regional Research Institute /ID# 224410
Verified postcode
Columbus, United States
University of Chicago Medical Center /ID# 271373
Verified postcode
Chicago, United States

Common questions

What is myelofibrosis?

Myelofibrosis is a rare blood cancer where the bone marrow (spongy tissue inside bones) becomes scarred, making it difficult to produce healthy blood cells, and the spleen often gets larger.

What is navitoclax?

Navitoclax is a new medicine being tested in this study for myelofibrosis. It has not yet been approved for general use.

Will I get to choose my treatment?

No, you will be assigned to a treatment group randomly, like drawing lots. Neither you nor your doctor will decide which treatment you receive.

How long will I be in the study?

You could be on the study treatment for about three years, or until your doctor advises otherwise, or you choose to stop.

What is 'Best Available Therapy' (BAT)?

BAT refers to the standard treatments that your doctor would normally consider the best option for your myelofibrosis outside of a clinical trial.