Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

ORACLE - Randomized Phase 3 Study evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) compared to Investigator’s Choice Therapy in Patient with Relapsed or Refractory Angioimmunoblastic T cell Lymphoma

This research study, called ORACLE, is looking into a new oral medication (a tablet) called azacitidine for adults with a specific type of blood cancer. This cancer is called angioimmunoblastic T-cell lymphoma (AITL), and the study is for patients whose cancer has either returned after treatment or didn't respond well to earlier treatments. The main goal is to see if this new tablet, azacitidine, is better than the usual treatments doctors currently use at stopping the cancer from growing or spreading. Researchers will also be looking at overall health and how long people live while on these treatments. The study aims to find more effective and easier-to-take options for people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

LYSARC

Enrolment target

Start

05 Dec 2024

Relapsed or Refractory Angioimmunoblastic T cell Lymphoma

What is this study about?

This study is called ORACLE, and it's looking into new ways to treat a specific type of blood cancer called angioimmunoblastic T-cell lymphoma (AITL). This cancer affects a type of white blood cell called T-cells. The study is for people whose cancer has either come back after they've had treatment before, or didn't get better with their previous treatments. Finding new and better treatments for these situations is very important.

In this study, researchers want to see if a new medicine, taken as a tablet, is effective. This tablet is called azacitidine, and it's being compared to other treatments that doctors currently use for this type of cancer. The main thing they want to find out is whether azacitidine can stop the cancer from getting worse for longer than the usual treatments. This is often called 'progression-free survival' in medical terms, meaning how long a person lives without their cancer getting worse.

Researchers will also be looking at other important aspects, such as how long people live in total (called 'overall survival' in medical terms) and if the treatments are safe and well-tolerated. The hope is that this study will lead to a new, easier-to-take treatment option that can help people with AITL live longer and have a better quality of life, especially when current treatments haven't worked or have stopped working.

Key takeaways

This study is for adults with angioimmunoblastic T-cell lymphoma that has come back or not responded to previous treatment.
It's comparing a new oral tablet (azacitidine) with standard treatments.
The main goal is to see if the new tablet can stop the cancer from getting worse for longer.
Participation involves regular clinic visits, taking medication, and close monitoring.
You have the right to withdraw from the study at any time.
Always discuss any research study with your own doctor.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit. The study is open to both men and women.

The most important condition is that you must have angioimmunoblastic T-cell lymphoma (AITL). This means your condition has either come back after you've already had treatment, or it didn't get better with the treatment you received before.

Other specific medical checks will be done by the study doctors to make sure it's safe for you to take part and that the study is right for your particular situation. These might include blood tests and checking your general health.

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 angioimmunoblastic T-cell lymphoma?
Has your cancer come back after previous treatment, or did it not respond to earlier treatments?
Are you willing to potentially receive either the new tablet or a standard treatment?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have screening tests to make sure it's suitable for you. If you qualify, you would be randomly assigned (like tossing a coin) to receive either the new oral azacitidine tablet or one of the standard treatments for your condition. These standard treatments might include medicines like bendamustine or gemcitabine, given as injections or infusions.

You would have regular visits to the clinic for check-ups, blood tests, and to monitor how you're feeling and how the treatment is working. These visits might be frequent at first and then become less often over time. You would take your assigned medication as instructed by the study team. The total duration of your participation would depend on how your cancer responds to treatment and how you are feeling, but you would be followed up for a period of time to track your health and the long-term effects of the treatment.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment that might be more effective than current options, or having your condition closely monitored by medical experts. However, there are also potential risks involved, as with any medical treatment. These could include side effects from the study medications – both the new tablet and the standard treatments – which will be explained in detail by your doctor. There's also no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical 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
France

Common questions

What kind of cancer is angioimmunoblastic T-cell lymphoma?

It's a rare type of blood cancer that affects certain white blood cells called T-cells, which are part of your immune system.

What does 'relapsed or refractory' mean?

It means the cancer has either returned after you've had treatment, or it didn't respond well to the treatment you received before.

What is azacitidine?

Azacitidine is a medicine that works by changing how cancer cells grow. In this study, it's being given as a tablet.

Will I know which treatment I'm getting?

You will be 'randomly assigned' to one of the treatments. This means it's like a lottery, so neither you nor your doctor will get to choose which one you receive if you join the main part of the study.

What are bendamustine and gemcitabine?

These are types of chemotherapy drugs that are sometimes used to treat lymphomas, and they are considered standard treatments in this study.