Active not recruitingPHASE2INTERVENTIONAL

Dexamethasone Added to Intensive Chemotherapy in Older Patients with Acute Myeloid Leukemia (AML)

This study is looking at whether adding a drug called dexamethasone to chemotherapy can improve treatment for older patients with Acute Myeloid Leukaemia (AML). AML is a cancer that affects the blood and bone marrow. We already have some evidence that dexamethasone might make chemotherapy work better. In this trial, patients will receive dexamethasone alongside their usual chemotherapy, both at the start of treatment and in the follow-up period. The main goal is to find out if this addition leads to longer periods where patients are free from cancer or if it takes longer for the cancer to return, compared to what we've seen with chemotherapy alone in previous studies.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

French Innovative Leukemia Organisation

Enrolment target

120

Start

24 Aug 2018

Estimated completion

31 Dec 2025

Acute Myeloid Leukemia

What is this study about?

You might be reading this because you or someone you know has been diagnosed with Acute Myeloid Leukaemia (AML). This is a type of cancer that affects the blood and bone marrow, which is the spongy material inside your bones that makes blood cells. For older patients with AML, doctors are always looking for ways to make treatments more effective.

This particular study is exploring whether adding a common medicine called dexamethasone to standard chemotherapy can improve how well your body responds to treatment. Dexamethasone is a type of steroid medicine that is already used for many health conditions. Recent research suggests it might also help chemotherapy drugs work better against AML cells, particularly in older patients. This study aims to confirm if this is true and if it leads to better outcomes for patients.

The main question we hope to answer is whether patients who receive dexamethasone along with their chemotherapy have a longer time before their cancer returns or whether their treatment is successful for a longer period. The findings from this study could help doctors decide on the best treatment plans for older patients with AML in the future.

Key takeaways

This study is testing if adding dexamethasone to chemotherapy helps older AML patients.
It aims to improve how long patients stay free from cancer.
Participants will receive standard chemotherapy plus dexamethasone.
Eligibility includes being over 60, specific AML types, and good general health.
You'll have regular check-ups to monitor your health and treatment.

Who may be eligible?

To join this study, you generally need to be over 60 years old and have been recently diagnosed with Acute Myeloid Leukaemia (AML). The type of AML you have is important; it needs to be what doctors call 'newly diagnosed' and fall into specific categories for how risky it is, generally not the highest risk types.

You also need to be well enough to receive strong chemotherapy treatment. Doctors will check your overall health, including how well your heart, liver, and kidneys are working, to make sure this treatment is safe for you. There are certain other health conditions or types of AML that would mean you can't join the study, like if you have a very specific type of AML or if your cancer has spread to your brain.

For women, you need to have gone through menopause to take part. Also, everyone joining the study will need to give their written permission, known as 'informed consent', after discussing all the details with the study team. This shows you understand what's involved.

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 over 60 years old?
Have you been recently diagnosed with Acute Myeloid Leukaemia (AML)?
Have your doctors said your AML is of 'intermediate' or 'favourable' risk?
Are your heart, liver, and kidney functions generally healthy?
Are you able to manage strong chemotherapy treatment?
If you are a woman, have you gone through menopause?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive dexamethasone in addition to the standard chemotherapy treatment. This will happen both during the initial strong treatment aiming to get rid of the cancer (called 'induction therapy') and during the follow-up treatments designed to keep the cancer from coming back (called 'post-remission therapy'). The chemotherapy drugs used are Idarubicin, Cytarabine, and Lomustine, and the doses and how they are given are carefully planned.

Throughout the study, you will have regular medical check-ups, blood tests, and other assessments to monitor your health and how you're responding to treatment. These appointments are designed to ensure your safety and track the progress of the study. The total duration of your participation will depend on your treatment plan and follow-up schedule, but the study team will provide you with a clear timeline. You'll also need to be able to attend all scheduled appointments.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more effective treatment for your AML, potentially leading to a longer period without the cancer returning compared to standard chemotherapy alone. However, adding an extra drug like dexamethasone could also increase side effects, and some people may experience side effects from the chemotherapy itself, which can be intense. The study team will carefully monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

CHU ANGERS - Maladies du sang
Verified postcode
Angers, France
Ch Avignon
Verified postcode
Avignon, France
CH de la Côte Basque - Hématologie
Verified postcode
Bayonne, France
CHRU JEAN MINJOZ - Hématologie
Verified postcode
Besançon, France
CH de Béziers - Hématologie
Verified postcode
Béziers, France
CHU Brest - Hôpital Morvan - Hématologie Clinique
Verified postcode
Brest, France
Clinique du Parc - Hématologie
Verified postcode
Castelnau-le-Lez, France
CHU Estaing - Hématologie Clinique Adulte
Verified postcode
Clermont-Ferrand, France
CHU Grenoble - Hématologie Clinique
Verified postcode
Grenoble, France
Institut Paoli-Calmettes - Hématologie 2
Verified postcode
Marseille, France
CHR de Mercy - Hématologie
Verified postcode
Metz, France
Hôpital Saint-Eloi - Hématologie Clinique
Verified postcode
Montpellier, France

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia, which is a cancer of the blood and bone marrow. It affects how your body makes healthy blood cells.

What is dexamethasone?

Dexamethasone is a type of steroid medicine. It's used for many medical conditions and in this study, we're testing if it helps chemotherapy work better for AML.

Will I still get chemotherapy?

Yes, if you join this study, you will still receive intensive chemotherapy. Dexamethasone would be given *in addition* to your standard chemotherapy drugs.

Why are older patients being studied?

This study focuses on older patients because finding the most effective and tolerable treatments for this age group with AML is a very important area for research.

What does 'intensive chemotherapy' mean?

Intensive chemotherapy means using strong combinations of drugs designed to kill cancer cells quickly. It often requires hospital stays and close monitoring.