Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2, open-label, single-arm rollover study to evaluate long-term Safety in subjects who participated in other Celgene sponsored CC-486 (oral Azacitidine) clinical trials in Hematological disorders

This study is checking the long-term safety of a medicine called azacitidine (also known as CC-486) when taken as a tablet. It's for adults who have blood disorders and have previously participated in other research studies involving this specific medicine. The main goal is to carefully track any side effects that might happen over a longer period, including how often they occur and how serious they are. Researchers want to understand if these side effects are linked to the medicine. Another important aim is to see how long people live after starting the treatment. By continuing to follow participants, the study hopes to gain a better understanding of the medicine's long-term effects on people's health.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Celgene Corp.

Enrolment target

Start

07 Sep 2023

Hematological Disorders

What is this study about?

Imagine you've been taking part in a study for a new medicine for a blood condition, and that study has finished. This new study is a chance to keep watching how that medicine, called azacitidine (also known as CC-486), affects you over a longer time. It's like a follow-up, specifically designed for people who have already taken this tablet in previous research studies.

The main thing researchers want to find out is the long-term safety of azacitidine tablets. This means they will carefully look for any side effects, how often they happen, how serious they are, and if they seem to be caused by the medicine itself. They'll also be tracking how long people live after starting the treatment. This kind of follow-up study is really important because it helps doctors understand the full picture of a medicine's effects, not just what happens in the short term.

By gathering more information on how people respond to azacitidine over a longer period, this study helps build a more complete understanding of its overall safety. This information is crucial for doctors and patients when making decisions about treatment for blood disorders in the future.

Key takeaways

This study is for adults with blood disorders who have previously used azacitidine tablets in a research study.
Its main goal is to understand the long-term safety and side effects of the medicine.
You'll receive azacitidine tablets and have close medical monitoring.
Researchers will track how often side effects happen and how serious they are.
Participation helps gather important information for future patient care.

Who may be eligible?

This study is open to adults who are 18 years old or older. There is no upper age limit, meaning people of any adult age can take part. Both men and women are welcome to participate.

The most important requirement is that you must have previously taken part in another research study for blood disorders that involved the medicine called CC-486 (also known as azacitidine tablets). This study is a continuation for people who have already started treatment with this specific medicine in a research setting.

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 blood disorder?
Have you taken part in a previous research study involving azacitidine (CC-486) tablets?
Are you able to attend regular clinic visits for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given azacitidine tablets, which come in different strengths (like 100mg, 150mg, 200mg, or 300mg). The doctors will decide which dose is right for you. Your participation will involve regular check-ups at the study clinic. During these visits, the study team will monitor your health very closely to see how you are responding to the medication and to check for any side effects. These check-ups will include physical examinations, blood tests, and discussions about how you are feeling.

The study is called a 'rollover' study, meaning it follows on from other earlier studies you might have been in. Therefore, the total length of your participation will depend on how long you have already been receiving the medication and how your health progresses. Doctors will keep you informed about what to expect regarding the duration of your involvement.

Potential risks and benefits

Taking part in this study could offer the potential benefit of continuing to receive treatment with azacitidine under close medical supervision, which might be helpful for your blood disorder. However, like all medicines, azacacitidine can have side effects, and these could be mild or severe. The study aims to monitor these very carefully to understand them better. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

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Unverified
Finland

Common questions

What is azacitidine (CC-486)?

Azacitidine (also known as CC-486) is a medicine that comes in a tablet form, and it's being studied as a treatment for certain blood disorders.

Why is this study being done?

This study wants to learn more about the long-term safety of azacitidine tablets by carefully watching people who have already used it in other studies for blood disorders.

What does 'single-arm' mean?

A 'single-arm' study means that everyone taking part will receive the same treatment (azacitidine tablets) and there isn't another group receiving a different treatment or a dummy pill.

Will I have to pay to be in the study?

No, you will not have to pay for the azacitidine medication or any study-related tests or appointments if you participate.

What kind of monitoring will I receive?

You will have regular medical check-ups, which will include examinations, blood tests, and discussions with the study doctors and nurses to monitor your health and any side effects.