RecruitingPHASE2INTERVENTIONAL

CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

This study is for people aged 50 and above who have been recently diagnosed with a type of blood cancer called acute myeloid leukaemia (AML). We are comparing a new treatment called CPX-351 against the usual strong chemotherapy. This is important because some people with AML have specific gene changes, often found in older patients, which mean standard treatments might not work as well for them. The study focuses on these particular types of AML. By joining, you would help researchers understand if CPX-351 can lead to better outcomes, like clearing the cancer more effectively, for patients with these genetic markers.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

248

Start

03 May 2023

Estimated completion

02 Feb 2030

Acute Myeloid Leukemia

What is this study about?

Acute myeloid leukaemia (AML) is a serious blood cancer that starts in the bone marrow. It affects how your body makes healthy blood cells. In this study, we are looking at people who have just been diagnosed with AML for the first time. We've learned that some people with newly diagnosed AML have certain changes in their genes that make their cancer act a bit differently, often making it harder to treat with standard chemotherapy, especially in older patients.

Because of this, we need to find new and better ways to treat AML, particularly for patients aged 50 and over who have these specific gene changes. This study is a 'Phase 2' trial, which means we are carefully testing a new treatment called CPX-351. We want to see how well it works compared to the standard strong chemotherapy treatment that is usually given. The main goal is to find out if CPX-351 can achieve better results, like getting rid of the leukaemia cells more completely.

By taking part, you would help doctors understand if CPX-351 can improve the chances of successful treatment for AML patients with these specific genetic features. This research is crucial for developing more effective and personalised treatments in the future, offering hope to many patients.

Key takeaways

This study is for newly diagnosed AML in people aged 50 and over with specific genetic markers.
It compares a new drug (CPX-351) with standard chemotherapy.
Participation involves regular hospital visits for tests and monitoring.
You will be randomly assigned to either the new drug or standard treatment.
The goal is to find better treatments for certain types of AML.
You can stop participating at any time.

Who may be eligible?

This study is looking for people who are at least 50 years old and have recently been diagnosed with acute myeloid leukaemia (AML) for the very first time. Your AML must also have certain genetic features that doctors call 'intermediate' or 'adverse risk', meaning it might be a bit harder to treat.

There are also some things that would mean you couldn't join. For example, if you've had certain other types of blood cancers before, or if your AML has specific well-known genetic changes that respond well to other standard treatments. You also can't have serious uncontrolled infections or other health problems that might make it unsafe for you to take part.

Women who could become pregnant will need to take a pregnancy test and agree to use effective birth control during the study. Men will also need to use birth control and should not try to father a child during the study and for three months afterwards. The study team will check your overall health and organ function to make sure it's safe for you to participate.

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 50 years old or older?
Have you been diagnosed with AML for the first time, very recently?
Do you have certain 'intermediate' or 'adverse risk' genetic markers in your AML?
Do you have good overall health and organ function?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have various tests to confirm your diagnosis and overall health. You would then be randomly assigned to receive either the new drug CPX-351 or the standard intensive chemotherapy. You wouldn't be able to choose which treatment you get. Both treatments are given through a drip into your vein.

Throughout the study, you would have regular hospital visits for blood tests, bone marrow checks, and other assessments to see how you are responding to the treatment and to monitor for any side effects. These visits will be more frequent at the beginning of the treatment, gradually becoming less often as time goes on. The treatment phase, including initial and follow-up treatments, could last several months. After your main treatment, you will continue to have follow-up checks for a longer period to monitor your health and any long-term effects. The study team will provide you with a detailed schedule of all appointments and tests.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but potential benefits include receiving expert medical care and access to a new treatment that might be more effective than standard care for your type of AML. However, like all medical treatments, both CPX-351 and standard chemotherapy have potential risks, including side effects like nausea, fatigue, infections, and changes to blood counts, which can be severe. The study team will closely monitor you for any side effects and manage them as best as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (35)

CHU Amiens Picardie site Sud
Verified postcode
Amiens, France· Recruiting
CHU d'Angers
Verified postcode
Angers, France· Not yet recruiting
CH Avignon
Verified postcode
Avignon, France· Recruiting
CHRU Jean Minjoz
Verified postcode
Besançon, France· Recruiting
Centre Hospitalier de Béziers
Verified postcode
Béziers, France· Recruiting
Hôpital Avicenne APHP
Verified postcode
Bobigny, France· Recruiting
Institut d'hématologie de Basse Normandie (IHBN)
Verified postcode
Caen, France· Recruiting
Hôpital d'Instruction des Armée (HIA)
Verified postcode
Clamart, France· Recruiting
CHU Estaing
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier Sud Francilien (CHSF)
Verified postcode
Corbeil-Essonnes, France· Recruiting
CHU Henri Mondor
Verified postcode
Créteil, France· Recruiting
Centre Hospitalier de Versailles, Site André Mignot
Verified postcode
Le Chesnay, France· Recruiting

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia. It's a type of cancer that affects the blood and bone marrow, where new blood cells are made.

What does 'newly diagnosed' mean?

It means you have only recently been told you have AML and haven't had any treatment for it yet, apart from possibly some medication to control your white blood cell count.

What is CPX-351?

CPX-351 is a new medication being tested. It's a combination of two chemotherapy drugs packaged together in a special way.

Will I definitely get the new drug?

No, you will be randomly chosen to receive either CPX-351 or the standard intensive chemotherapy. You won't get to choose.

What does 'intermediate or adverse risk' AML mean?

This refers to certain features of your AML, often involving specific gene changes, that help doctors understand how the leukaemia might behave and how it might respond to treatment.

How to find out more

valerie Foussat

foussat.v@chu-nice.fr +33492034011 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.