Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to assess the effect of CC-95251 alone and in combination with anti-cancer drugs in subjects with Acute Myeloid Leukemia and Myelodysplastic Syndromes

This research study is about a new drug called CC-95251. It's for adults who have acute myeloid leukaemia (AML) or myelodysplastic syndromes (MDS) – these are types of blood and bone marrow cancers. The main goal is to find out if CC-95251 is safe enough for people to take, and to see what effects it has on the body. Doctors will test it by itself and also combine it with other medicines that are already used to treat cancer. This is an early stage study, meaning it's one of the first times this drug is being tested in people. The information gathered will help doctors decide if it's worth exploring further. It is not currently active for recruitment, but it’s still important to understand the progress made in finding new treatments for AML and MDS.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Celgene Corp., Celgene Corp.

Enrolment target

153

Start

01 Feb 2024

Acute Myeloid Leukemia and Myelodysplastic Syndromes

What is this study about?

This study is an important step in developing new ways to treat acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). AML and MDS are serious conditions that affect your blood and bone marrow. Researchers are testing a new medicine, called CC-95251, to see if it could help. This type of research is vital because it can lead to better treatments and improve the lives of people with these conditions.

The main purpose of this study is to learn more about CC-95251. Doctors want to understand how it behaves in the human body, for example, how much to give and if it has any side effects. They will also look at whether it can help to fight the cancer cells. This is a very early stage of testing for the drug, known as a Phase 1 study, which means it’s one of the first times it’s being given to people.

Researchers will observe how people respond to CC-95251 when it's given alone and when it's given alongside other cancer medicines that are already in use. This helps them work out the best way to use the new drug in the future. While this particular study is no longer recruiting new participants, the findings from studies like this are crucial for developing new medicines for people with AML and MDS.

Key takeaways

This study investigated a new drug called CC-95251 for AML and MDS.
It was an early-stage (Phase 1) study focused on safety and dosage.
The drug was tested alone and combined with other cancer medicines.
The study aimed to understand the drug's effects in people.
This research has now finished recruiting participants.

Who may be eligible?

This study was open to adults aged 18 and over. There was no upper age limit, meaning older adults could also take part.

Both men and women were eligible to join the study if they met the specific medical requirements for having acute myeloid leukaemia or myelodysplastic syndromes.

However, it's important to remember that this study is no longer looking for new participants. For any future studies, doctors will always check your health and medical history very carefully to make sure a study is safe and right for 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 an adult aged 18 or older?
Do you have a diagnosis of Acute Myeloid Leukaemia (AML)?
Do you have a diagnosis of Myelodysplastic Syndromes (MDS)?
Have you discussed clinical trials with your specialist doctor?

Answer every question to see your result.

What does participation involve?

As this study has already taken place, we can only describe generally what taking part in a study like this often involves. Typically, participants would have had regular visits to the hospital or clinic. During these visits, doctors and nurses would perform various assessments, such as blood tests, physical examinations, and scans, to monitor health and see how the new drug is working.

Participants would have received the study medication (CC-95251) according to a specific schedule, either on its own or with other cancer drugs. They would also be carefully monitored for any side effects. The total duration of participation varies greatly between studies, but early-stage trials often involve a period of active treatment and then regular follow-up appointments for a number of months or even longer, even after stopping the study drug, to track long-term safety and results.

Potential risks and benefits

Taking part in early-stage clinical trials like this carries both potential benefits and risks. A potential benefit is gaining access to a new treatment that isn't yet widely available, which might help when other standard treatments haven't worked. However, there's no guarantee that the new drug will be effective, and like all medicines, CC-95251 could have side effects, some of which might be serious or currently unknown. Participants always have the right to withdraw from a study at any time, for any reason, without it affecting their usual medical care.

Locations (5)

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

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Unverified
France
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Unverified
Norway
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Unverified
Italy
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Unverified
Sweden
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Unverified
Spain

Common questions

What is acute myeloid leukaemia (AML)?

AML is a type of cancer that starts in the bone marrow, the soft centre of your bones, where new blood cells are made. It causes the bone marrow to make too many abnormal white blood cells.

What are myelodysplastic syndromes (MDS)?

MDS are a group of conditions where the bone marrow doesn't make enough healthy blood cells. This can lead to problems like anaemia, infections, or bleeding.

What does 'Phase 1' study mean?

A Phase 1 study is an early stage of research where a new medicine is given to people for the first time. The main aim is to check if it's safe and to find the right dose, rather than to see if it cures the condition.

Is this study still recruiting participants?

No, this specific study is no longer looking for new people to join. It has already finished its recruitment phase.

Why is it important to test new drugs?

Testing new drugs helps doctors find better and more effective ways to treat serious illnesses like AML and MDS, which can improve how people live with these conditions and extend their lives.