Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study testing increasing amounts (doses) of CC-91633 to find out what dose can be tolerated without serious side effects in patients with acute myeloid leukemia (AML) that has come back after treatment or cannot be cured or treated by any other known therapies, also called relapsed or refractory AML (R/R AML) and in patients with relapsed or refractory higher-risk myeloid dysplastic syndrome (R/R HR-MDS).

This research study, called a Phase I trial, is looking at a new drug known as CC-91633. It's for adult patients who have a type of blood cancer called acute myeloid leukaemia (AML) or a higher-risk form of myelodysplastic syndrome (MDS). These cancers are often quite serious, and for the people we're inviting to join, their cancer has either come back after past treatments or isn't responding to other available medicines. The main goal of this first stage of testing is to carefully increase the amount (dose) of CC-91633 given to find the highest dose that can be tolerated without causing serious side effects. This helps researchers understand how much of the medicine can be safely given before moving on to larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Celgene Corp.

Enrolment target

Start

13 Mar 2023

Acute myeloid leukemia or myelodysplastic syndrome of high risk group,that has come back after treatment or cannot be cured or treated by any other known therapies.

What is this study about?

This study is a very early-stage research project, often called a Phase I clinical trial. It's focused on a new medicine, CC-91633, for adults with specific blood cancers: Acute Myeloid Leukaemia (AML) or a form of Myelodysplastic Syndrome (MDS) that doctors consider to be higher risk. For the patients we're looking to include, their cancer has either come back after they've had treatment before, or it hasn't responded to other medicines available to them. This means their treatment options might be limited, and new approaches are urgently needed.

The main purpose of this particular study is to explore the new medicine's safety. When a new drug is first given to people, researchers need to find out what dose is safe to give. They start with very low doses and carefully increase them step-by-step for different groups of patients, watching closely for any side effects. The aim is to find the highest amount of the medicine that people can take without experiencing serious problems.

Finding a safe dose is a crucial first step in developing any new medicine. If CC-91633 is found to be safe enough in this study, and if it shows any early signs of helping patients, it could potentially move on to larger studies in the future. These larger studies would then look more closely at how well it treats the cancer.

Key takeaways

This is an early-stage study (Phase I) of a new medicine for certain blood cancers.
It aims to find the safest dose of the new medicine, CC-91633.
The study is for adults with AML or high-risk MDS that has returned or is hard to treat.
Participants will receive the new medicine and have regular medical checks.
There are potential risks, like side effects, and potential benefits, like access to a new treatment.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, there are some important things you need to know. First, you must be 18 years old or older – there's no upper age limit. The study is open to everyone, regardless of whether you are male or female.

Crucially, you would need to have been diagnosed with either Acute Myeloid Leukaemia (AML) or a higher-risk form of Myelodysplastic Syndrome (MDS). For this study, your cancer must also have either returned after you've had treatment for it, or it hasn't responded to other treatments that your doctors have tried. This means your current treatment options might be limited, and your doctor believes this study could be an option for you.

There will be other health checks and tests to make sure you are suitable and that taking part would be safe for you. Your study doctor and nurse will discuss all these details with you thoroughly.

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 Acute Myeloid Leukaemia (AML) or a higher-risk Myelodysplastic Syndrome (MDS)?
Has your cancer come back after previous treatment, or is it not responding to other medicines?
Are you willing to attend regular hospital/clinic visits for assessments and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new study medicine, CC-91633. The exact amount and how often you take it will depend on the dose group you are in, as the study is designed to find the safest dose. You will have regular visits to the hospital or clinic, which will involve various assessments. These will include physical examinations, blood tests, and possibly other scans or procedures to monitor your health and how the medicine is affecting your body and your cancer. The length of time you participate will vary depending on how you respond to the treatment and the study's requirements. You will be closely followed by the study team throughout your involvement. Even after treatment finishes, there might be follow-up appointments to check on your long-term health. The study team will explain the full schedule of visits and what each involves.

Potential risks and benefits

Participating in a study like this might offer a potential benefit: you could gain access to a new medicine that is not yet widely available, which might help if other treatments haven't worked for your cancer. However, as with any new medicine, there are potential risks, and you may experience side effects. We don't yet know all the possible side effects, which is why studies like this are done. The study team will explain all known and possible side effects to you. It's very important to remember that you have the right 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.

—
Unverified
Spain

Common questions

What is a 'Phase I' clinical trial?

A Phase I study is the first time a new medicine is tested in people. The main goal is to find a safe dose and see how the body handles the medicine.

What kind of cancers is this study for?

This study is for adults with Acute Myeloid Leukaemia (AML) or a higher-risk type of Myelodysplastic Syndrome (MDS) that has either returned or isn't responding to other treatments.

What is CC-91633?

CC-91633 is a new investigational medicine being tested in this study. It's not yet approved for general use.

Will I get treatment if I join?

Yes, if you join, you will receive the study medicine, CC-91633. However, the exact dose will be carefully managed as part of finding a safe amount.

Can I stop being part of the study once I've started?

Yes, you can choose to stop participating in the study at any point, and your decision will not affect your future medical care.