Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

LAMSA2020: “A phase II randomized study to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first remission”

This study is for older patients (aged 60 and above) who have acute myeloid leukaemia (AML), a type of blood cancer, and whose cancer is currently in remission (meaning the signs of cancer have gone away after initial treatment). The study compares two different combinations of medicines: one using Venetoclax with Cytarabine, and the other using Idarubicin with Cytarabine. Both combinations are given after the first round of treatment to try and prevent the cancer from coming back. The aim is to see which of these two approaches is more effective in keeping the AML in remission for longer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

French Innovative Leukemia Organization

Enrolment target

114

Start

23 Jul 2024

elderly patients (> = 60 years) with Acute Myeloid Leukemia

What is this study about?

This research study, called LAMSA2020, is designed to help older patients who have been diagnosed with acute myeloid leukaemia (AML). AML is a cancer that affects the blood and bone marrow, the spongy tissue inside some bones where blood cells are made. After someone with AML has their first treatment and goes into remission (meaning the cancer cells are no longer detectable), doctors want to find the best way to keep the cancer from returning.

This study is looking at two different approaches for this 'post-remission therapy'. One approach uses a drug called Venetoclax alongside Cytarabine, and the other uses Idarubicin with Cytarabine. Both Venetoclax and Idarubicin are medicines that work to fight cancer cells, and Cytarabine is a standard chemotherapy drug often used for AML.

The main goal of this study is to compare these two treatment combinations to see which one is more effective at preventing the AML from coming back in older patients (aged 60 and above). By participating, patients could help doctors understand which treatment is better for keeping AML in remission, potentially improving future care for others with this condition.

Key takeaways

This study compares two different anti-cancer drug combinations for older AML patients.
It's for people aged 60 and over whose AML is currently in remission after initial treatment.
The goal is to find which treatment is better at stopping the cancer from coming back.
You would be randomly assigned to one of the two treatment groups.
Regular hospital visits and tests would be part of your participation.

Who may be eligible?

This study is specifically for people aged 60 and over who have been diagnosed with acute myeloid leukaemia (AML). To be considered, your AML must currently be in a state of 'remission'. This means that after your first course of treatment, tests show that there are no longer signs of the cancer.

Doctors will also need to check other aspects of your health to make sure you are well enough to take part in the study and safely receive the treatments. This involves looking at your medical history and doing various tests.

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 60 years old or older?
Have you been diagnosed with acute myeloid leukaemia (AML)?
Is your AML currently in remission after your first treatment?
Are you generally well enough to undergo further treatment, as assessed by your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive one of the two treatment combinations (either Venetoclax with Cytarabine, or Idarubicin with Cytarabine). This is like flipping a coin to decide which group you are in, and it's done to ensure a fair comparison between the treatments.

Both treatment combinations involve taking medications, which will be given according to a specific schedule determined by the study doctors. You will have regular appointments at the hospital, which will include blood tests, physical examinations, and other assessments to monitor your health and how well the treatment is working. The study team will explain exactly how often these visits are needed and for how long. There will also be follow-up appointments after your treatment period to see how you are doing in the longer term.

Potential risks and benefits

Participating in a clinical trial might offer the potential benefit of receiving a new or different treatment approach that doctors hope could be more effective. However, there are also potential risks involved, as all medications can have side effects. You might experience side effects from the drugs, and there’s no guarantee that the treatment you receive will work for you. The study team will explain all known side effects and help manage any that you experience. Remember, you can choose 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 'remission'?

Remission means that the signs and symptoms of your cancer have reduced or disappeared after treatment. It doesn't always mean the cancer is completely cured, but it's a very positive step.

What is acute myeloid leukaemia (AML)?

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

Why are they studying older patients specifically?

Older patients with AML can sometimes react differently to treatments, so this study focuses on finding the best ways to keep the cancer away specifically for people aged 60 and over.

Will I know which treatment I'm getting?

You will be told which treatment combination you have been randomly assigned to receive in the study.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatments or any tests that are part of the research. Your travel costs to the hospital might be reimbursed.