Active not recruitingPHASE4INTERVENTIONAL

CINC424A2X01B Rollover Protocol

This is a long-term study for people who are currently in another clinical trial and are already receiving treatment with either ruxolitinib alone or ruxolitinib combined with panobinostat. If your doctor believes you are still getting a benefit from this treatment, this study allows you to continue taking it. The main purpose is to look at the long-term safety of these medicines. While the study won't measure if the treatment is still working in detail, it will keep track of your safety and your doctor's assessment of how well you're doing. This helps researchers understand more about these treatments over a longer period.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Novartis Pharmaceuticals

Enrolment target

279

Start

05 Mar 2015

Estimated completion

16 Sep 2027

Primary Myelofibrosis Polycythemia Vera Graft Versus Host Disease Acute Myeloid Leukemia Thalassemia

What is this study about?

Imagine you're already in a study for a new medicine, and it's really helping you. This study is like a special extension programme designed for people just like you. It's for patients who have been taking either ruxolitinib, or a combination of ruxolitinib and panobinostat, as part of an earlier trial and whose doctors believe they are still benefiting from the treatment. It's a way for you to safely continue receiving your medication.

The main goal of this particular study is to keep a close eye on the long-term safety of these medicines. Because you've already been taking them for a while, researchers want to understand how they work in your body over an even longer period. They won't be focused on proving if the treatment works (that was done in the earlier trial), but rather on making sure it remains safe for you.

By taking part, you're helping doctors gather important information that can benefit many others in the future who might receive these treatments. It's about ensuring these medicines are not only effective but also safe for long-term use.

Key takeaways

This study is for patients already getting ruxolitinib in another trial.
It allows you to continue your current treatment if it's still helping you.
The main goal is to check the long-term safety of your medication.
You'll have regular checks with your doctor to monitor your health.
You can leave the study at any time.
Your doctor determines if you continue to benefit and can stay in the study.

Who may be eligible?

You might be able to join this study if you are already taking part in another study sponsored by Novartis or Incyte, and are receiving ruxolitinib by itself or with panobinostat. An important part of joining is that your doctor must believe you are still getting a clear benefit from the treatment you're on, and you should not have shown any signs that your illness is getting worse.

Also, you need to have followed all the rules of your previous study. If you've had to stop your treatment in the earlier study for any reason, or if your condition is now being treated with these medicines as a standard treatment that's paid for by the NHS or other similar system in your country, then this study might not be suitable for you.

For women, you cannot join if you are pregnant or breastfeeding. If you could become pregnant, you'll need to agree to use very effective birth control throughout the study and for a month after stopping the treatment.

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 currently in another study using ruxolitinib (or ruxolitinib with panobinostat)?
Does your doctor believe this treatment is still helping you?
Have you followed all the rules of your current study?
Do you have no signs that your illness is getting worse?
Are you a woman who is not pregnant or breastfeeding, and willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the same treatment (either ruxolitinib, or ruxolitinib with panobinostat) as you were in your previous clinical trial. You'll have regular visits with your study team to check on your health and make sure the treatment is still safe for you. These visits will involve health checks and possibly some blood tests.

The study focuses on monitoring your safety over time. While the study doesn't have a set end date for each person (it's for as long as you're benefiting), your doctor will regularly review your condition and decide if continuing the treatment is still the best option for you. You won't need to do anything different from what you're already doing in your current study, but it allows you to get your medication through the study for longer.

Potential risks and benefits

The potential benefit of joining this study is that you can continue to receive a treatment that your doctor believes is helping you. This can be important if your previous study is ending and you would otherwise have to stop the medication. As with any medication, there are potential risks, which include side effects that you might already be experiencing or new ones that could develop over time. Your study team will carefully monitor you for any health changes or side effects. Remember, joining any study is completely your choice, and you are free to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (97)

Novartis Investigative Site
Verified postcode
Darlinghurst, Australia
Novartis Investigative Site
Verified postcode
Herston, Australia
Novartis Investigative Site
Unverified
Wooloongabba, Australia
Novartis Investigative Site
Verified postcode
Bedford Park, Australia
Novartis Investigative Site
Verified postcode
Box Hill, Australia
Novartis Investigative Site
Verified postcode
Clayton, Australia
Novartis Investigative Site
Unverified
Franston, Australia
Novartis Investigative Site
Verified postcode
Perth, Australia
Novartis Investigative Site
Verified postcode
St Leonards, Australia
Novartis Investigative Site
Verified postcode
Leuven, Belgium
Novartis Investigative Site
Verified postcode
Antwerp, Belgium
Novartis Investigative Site
Verified postcode
Bruges, Belgium

Common questions

What is a 'rollover protocol'?

It's a way for patients who are already in one study and benefiting from treatment to continue that treatment in a new, long-term study.

Will I get a new medicine in this study?

No, you will keep taking the same medicine (ruxolitinib, or ruxolitinib with panobinostat) that you were receiving in your previous study.

How long will I be in this study?

The study aims for long-term safety. You can continue as long as your doctor believes the treatment is helping you and it remains safe.

What is the main purpose of this study?

The main purpose is to gather more information about the long-term safety of the treatments you are already receiving.

Will the study check if the medicine is still working?

While your doctor will assess your overall benefit, this study mainly focuses on safety rather than detailed measurements of how well the treatment is working.