RecruitingPHASE2INTERVENTIONAL

Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT

This study is looking at adults with Acute Myeloid Leukemia (AML), a type of blood cancer, who are ready for a stem cell transplant. The main goal is to compare two different drug combinations given before the transplant to prepare the body. These combinations are called 'CloB2A2' (which uses Clofarabine) and 'FB2A2' (which uses Fludarabine). Doctors want to find out if the CloB2A2 combination is better at stopping the cancer from coming back and helping people live longer after their transplant. The study will also look at the costs involved and how the treatments affect a patient's quality of life.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Nantes University Hospital

Enrolment target

302

Start

14 Sep 2023

Estimated completion

14 Sep 2028

Acute Myeloid Leukemia in Remission

What is this study about?

When someone has Acute Myeloid Leukemia (AML), especially after a stem cell transplant, there's a risk that the cancer might come back. Doctors are always looking for ways to reduce this risk and help patients live longer and healthier lives. One way they try to do this is by using powerful medicines before the stem cell transplant to remove as many cancer cells as possible. This preparation is called a 'conditioning regimen.'

This particular study is focusing on comparing two different drug combinations used in these conditioning regimens. One combination includes a drug called Clofarabine, and the other includes Fludarabine. Previous observations have suggested that Clofarabine might lead to better results for AML patients, meaning the cancer is less likely to return and patients live longer. However, these were just observations, and doctors need to formally test this in a careful study.

The main aim of this study is to definitively find out if the Clofarabine-based combination is indeed better than the Fludarabine-based one for AML patients having a stem cell transplant. They are hoping to see a significant improvement in how many patients are still alive two years after their transplant with Clofarabine. Beyond just survival, the study will also look at how these treatments affect a patient's daily life and their well-being, as well as the costs involved, to get a complete picture.

Key takeaways

This study compares two drug combinations (Clofarabine vs. Fludarabine) for adults with AML.
It aims to improve survival rates after a stem cell transplant.
The study also looks at quality of life and costs.
It's for adults aged 18+ with AML in remission who need a reduced-intensity transplant.
Participation involves 2 years of follow-up after the transplant.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have Acute Myeloid Leukemia (AML). You would usually have had some treatment already, and your AML would need to be in remission, meaning there are very few or no cancer cells found when they check your bone marrow.

You would need to be suitable for a specific type of less intense stem cell transplant preparation. This usually means you are 60 years old or more, or you are under 60 but have other health conditions that make a stronger treatment too risky. You must also have a suitable donor for your stem cells, whether they are a relative or an unrelated person, and the stem cells would need to come from their blood, not bone marrow.

You should generally feel well enough to participate in daily activities without too much trouble. If you are a woman of childbearing age, strict contraception methods stable for the study period will be required, or you must be past menopause or have had certain surgeries.

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 Leukemia (AML) and is it currently in remission?
Are you able to have a reduced-intensity stem cell transplant?
Do you have a suitable stem cell donor (related or unrelated)?
Are you generally well enough for daily activities?
If you are a woman of childbearing age, are you willing to use strict contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the total length will be 5 years. This includes up to 3 years when patients are joining the study, and then each patient will be followed for 2 years after their stem cell transplant. During this time, you would receive either the Fludarabine drug combination or the Clofarabine drug combination as part of your transplant preparation. Both combinations also involve Busulfan and ATG.

Throughout the study, you will have regular visits with your medical team. These visits will involve blood tests, physical examinations, and other checks to monitor your health, how well the treatment is working, and if you have any side effects. You will also be asked questions about your quality of life to understand how the treatment affects you day-to-day. The Clofarabine medication will be provided to all participating hospitals. You will be closely monitored by your medical team throughout the study period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a treatment combination that could prove to be more effective than standard approaches, potentially improving your chances of long-term survival. However, there are also risks, as these are powerful cancer drugs with potential side effects, which your medical team will discuss with you. You will be closely monitored for any reactions or side effects. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (23)

CHU de Nantes
Verified postcode
Nantes, France· Recruiting
CHU Amiens
Verified postcode
Amiens, France· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
CHU Besançon
Verified postcode
Besançon, France· Recruiting
CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CHU Brest
Verified postcode
Brest, France· Recruiting
CRLC Caen
Verified postcode
Caen, France· Recruiting
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
APHP Créteil
Verified postcode
Créteil, France· Recruiting
CHU Grenoble
Verified postcode
Grenoble, France· Recruiting
CHRU Lille
Verified postcode
Lille, France· Not yet recruiting
CHU Limoges
Verified postcode
Limoges, France· Recruiting

Common questions

What is Acute Myeloid Leukemia (AML)?

AML is a fast-growing cancer of the blood and bone marrow, which are in the soft parts of your bones.

What is a stem cell transplant?

A stem cell transplant replaces your unhealthy blood cells with healthy ones, often from a donor. It's a key treatment for AML.

What does 'remission' mean?

Remission means that the signs and symptoms of your cancer have decreased or disappeared. In this study, it means very few or no cancer cells are found.

What is a 'conditioning regimen'?

This is the name for the powerful drug treatment given just before a stem cell transplant to prepare your body and remove cancer cells.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one of the treatment groups, and sometimes neither you nor your doctor will know which one you are receiving until the study is complete. Your doctor will explain this process fully.

How to find out more

Patrice CHEVALLIER, Pr

patrice.chevallier@chu-nantes.fr Official trial record

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