Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Phase I / II, open label, dose escalation part (phase I) followed by non-comparative expansion part (phase II), multi-centre study, evaluating safety, pharmacokinetics and efficacy of S65487, a Bcl2 inhibitor combined with azacitidine in adult patients with previously untreated acute myeloid leukemia not eligible for intensive treatment

This research is a Phase I/II study looking into a new treatment for Acute Myeloid Leukaemia (AML), a type of blood cancer. We're testing a new drug, S65487, alongside a drug already used, azacitidine. This study is specifically for adults newly diagnosed with AML who aren't suitable for strong chemotherapy treatments. The main goals are to find a safe dose for S65487 (Phase I) and then to see how effective the combination treatment is at putting the cancer into remission (Phase II). We'll also be closely watching for any side effects and how the body handles the medicine. The aim is to find better treatment options for people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Institut De Recherches Internationales Servier IRIS

Enrolment target

Start

07 Jun 2024

Acute Myeloid Leukemia (AML)

What is this study about?

This clinical trial is designed to investigate a new treatment approach for adults diagnosed with Acute Myeloid Leukaemia (AML). AML is a serious type of cancer that affects the blood and bone marrow. This study is particularly for patients who have not received treatment before and for whom intensive chemotherapy, a very strong form of treatment, isn't an option due to their health or other factors.

The study involves combining a new experimental drug, called S65487, with another medication, azacitidine, which is already used to treat AML. The trial has two main parts: Phase I and Phase II. In Phase I, we'll start with small doses of S65487 and gradually increase them to find the safest and most effective dose when given with azacitidine. During this phase, doctors will be carefully monitoring participants for any side effects and how their bodies react to the medicine.

Once a safe dose is found, the study moves into Phase II. In this part, more patients will receive the combination treatment at the established safe dose. The main goal of Phase II is to determine how well the treatment works to reduce or get rid of the leukaemia cells. This includes looking at whether the cancer goes into remission, meaning there are no signs of the disease. Researchers hope this study will help find better, safer, and more effective treatments for people living with AML.

Key takeaways

This study tests a new two-drug treatment (S65487 and azacitidine) for AML.
It's for adults newly diagnosed with AML who can't have intensive chemotherapy.
The first phase looks for a safe dose; the second phase checks how well it works.
You'll have regular medical checks, blood tests, and bone marrow samples.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. Both men and women can take part. A key requirement is that you have been diagnosed with Acute Myeloid Leukaemia (AML) and have not received any treatment for it yet. Additionally, your medical team must have determined that you are not suitable for intensive chemotherapy, which is a very strong type of cancer treatment.

There might be other health conditions or medications that would prevent you from joining, as the researchers need to ensure the study is safe and appropriate for everyone involved. Your doctor will carefully review your medical history to see if you meet all the necessary requirements.

This study is for people who are newly diagnosed with AML and need an alternative to intensive chemotherapy.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
Have you NOT had any treatment for your AML yet?
Has your doctor told you that intensive chemotherapy is not suitable for you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given the new drug S65487 through an infusion (into your vein), along with azacitidine, another medication that will be injected or also given through infusion. You may also be given a tablet called Posaconazol, which is used to prevent infections. You will have regular appointments at the hospital or clinic. These visits will involve various checks, such as measuring your vital signs (like blood pressure and heart rate), having blood tests to see how the drugs are affecting your body, and having electrocardiograms (ECGs) to check your heart.

Doctors will also take samples of your bone marrow, which involves a small procedure to collect a sample from inside your bone, to see how the treatment is affecting the leukaemia cells. They will closely watch for any side effects you might experience and adjust your medication if needed. The study involves several cycles of treatment, and the duration varies based on how your body responds. You will be monitored throughout the treatment and for a period afterwards. The whole study process, including follow-up, could last for an extended period, which your doctor will discuss with you.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to participating in this study. The potential benefit is that this new combination therapy might help to control your Acute Myeloid Leukaemia, possibly leading to remission, especially if intensive chemotherapy isn't an option for you. However, there's no guarantee the treatment will work. Potential risks include experiencing side effects from the medications, which will be closely monitored by the medical team. These side effects can range from mild to severe, and they will be explained to you in detail before you decide to join. It is important to know that taking part in any clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

—
France
—
Spain

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that starts in the bone marrow, the soft tissue inside your bones, and affects the blood cells.

Why is this study important for me?

This study is for people with AML who can't have standard strong chemotherapy and could offer a new treatment option for your condition.

What is S65487?

S65487 is a new experimental drug being tested to see how it works against leukaemia cells when combined with another drug, azacitidine.

Will I get a placebo (a dummy drug) in this study?

No, this study does not include a placebo group. All participants will receive the active study drugs.

How long will I be in the study?

The length of your participation will depend on how you respond to the treatment, but it will involve several treatment cycles and a follow-up period.