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

A Dose Finding Phase 1 Study of CC-96191 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia

This study is a very early-stage trial, referred to as a Phase 1 study. Its main goal is to find the safest and most effective dose of a new experimental medication called CC-96191. This drug is being investigated for adults aged 18 and over who have acute myeloid leukaemia (AML). This is a type of blood cancer. The study is for people whose AML has either returned after treatment (relapsed) or has not gotten better with standard treatments (refractory). This will be the first time this new drug is given to human patients. Because it's an early study, researchers will be carefully checking how the drug affects the body and if it has any side effects as they try to find the right amount to give.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Celgene Corp.

Enrolment target

Start

14 Nov 2022

Relapsed or Refractory Acute Myeloid Leukemia

What is this study about?

This is a very early research study, often called a Phase 1 trial. Think of it as the first step in testing a new medicine in people. The main aim is to find out the safest and most effective amount, or 'dose', of a new experimental drug called CC-96191. Researchers will also be looking to see what effects the drug has on the body and if there are any side effects.

The study is for adults who have a type of blood cancer called acute myeloid leukaemia (AML). This is a fast-growing cancer that affects the blood and bone marrow, which is where new blood cells are made. The study is specifically for people whose AML has come back after treatment (this is called 'relapsed AML') or hasn't responded to previous treatments (this is called 'refractory AML').

By taking part, you could be helping researchers understand if this new drug might be a helpful treatment option in the future. It's important to remember that because this is a very early study, we don't yet know if the drug will be effective in treating AML or what all its side effects might be.

Key takeaways

An early-stage study for a new drug called CC-96191.
For adults with acute myeloid leukaemia (AML) that has come back or not responded to treatment.
Aims to find the safest and most effective dose of the new drug.
Study participants will be closely monitored for effects and side effects.
You would contribute to medical research for future treatments.

Who may be eligible?

This study is open to adults aged 18 years and older. There is no upper age limit, meaning people of any adult age can be considered.

To be considered for this study, you must have acute myeloid leukaemia (AML) which has either returned after you've had treatment for it, or it hasn't responded to the treatments you've received. This means your doctors have determined that your AML isn't currently under control with standard therapies.

Both men and women can take part in this study. However, before you can join, the study doctors will need to review your full medical history and current health to make sure that taking part would be safe and appropriate 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 18 years old or older?
Have you been diagnosed with acute myeloid leukaemia (AML)?
Has your AML come back after treatment, or not responded to past treatments?
Are you able to attend regular hospital or clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests to check your current health and confirm if you are suitable. If you are, you would then receive the experimental drug, CC-96191. Because this is an early-stage study focused on finding the right dose, you would be very closely monitored by the study team.

This would involve regular visits to the hospital or clinic for check-ups, blood tests, and other assessments. These visits are important to see how your body is reacting to the drug, what side effects you might be having, and if the drug is having any effect on your leukaemia. The exact number and frequency of visits, as well as the total length of time you would be involved in the study, would be explained fully by the study team. You would likely receive the medication for a period, with follow-up appointments after. The total duration will vary for each person depending on how they respond to the treatment.

Potential risks and benefits

Potential benefits of taking part might include access to a new experimental treatment that isn't yet widely available. While there's no guarantee the drug will help your leukaemia, it could potentially slow its progress or improve your condition. You would also be contributing to medical research, which could help future patients. However, there are also potential risks related to taking an experimental drug. These could include side effects, some of which might be serious or currently unknown. The study doctors will explain all known side effects. 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 is a 'Phase 1' study?

A Phase 1 study is the very first step where a new drug is given to humans. Its main purpose is to find the safest dose and see how the drug affects the body.

What is acute myeloid leukaemia (AML)?

AML is a type of cancer that starts in the blood-forming cells of the bone marrow. It causes too many abnormal white blood cells to be made.

What does 'relapsed or refractory' mean?

It means your AML has either come back after treatment (relapsed) or hasn't improved with previous treatments (refractory).

Will I definitely get the new drug?

If you meet all the study requirements, you would receive the experimental drug. This study doesn't compare it to a dummy drug (placebo) or another treatment.

Will I have to pay to be in the study?

No, you should not have to pay for the study drug or for the tests and visits that are part of the study.