RecruitingPHASE2INTERVENTIONAL

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

This research study is investigating a new way to treat acute myeloid leukaemia (AML), a type of blood cancer. Specialists are looking into a treatment plan that combines Gilteritinib, a newer medication, with two established drugs, Venetoclax and Azacitidine. This particular study is for people with AML who have a specific genetic change called a FLT3 mutation. It's also designed for patients who, for various reasons, aren't suitable for very intensive chemotherapy treatments, which are usually quite strong. The main goal is to find the best amount (dose) of Gilteritinib to use in this combination, making sure it's both safe and effective for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Technische Universität Dresden

Enrolment target

Start

25 Apr 2025

Estimated completion

01 Apr 2030

AML - Acute Myeloid Leukemia

What is this study about?

This study is about a type of blood cancer called Acute Myeloid Leukaemia, or AML. In AML, the bone marrow (the spongy centre of your bones) makes too many abnormal white blood cells. This can stop your body from making healthy blood cells.

Researchers are testing a new approach, combining Gilteritinib with two other drugs, Venetoclax and Azacitidine, which are already used to treat AML. This specific study is focused on patients who have a particular change in their genes, called a FLT3 mutation. This gene change can affect how AML behaves. It’s also for people who are not able to have the very intensive chemotherapy treatments that are often used for AML.

The main aim is to find the most effective and tolerable dose of Gilteritinib when given with the other two medications. This means they want to find an amount that works well to fight the cancer but doesn't cause too many side effects, improving treatment options for this group of patients.

Key takeaways

This study is for adults with newly diagnosed AML.
It's specifically for those with a FLT3 gene mutation.
It's for patients who cannot receive strong, intensive chemotherapy.
It combines a new drug (Gilteritinib) with two standard drugs.
The aim is to find the best dose of Gilteritinib in this combination.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to have been recently diagnosed with Acute Myeloid Leukaemia (AML) and have at least 20% abnormal cells in your bone marrow. An important point is that your AML must have a specific gene change called a FLT3 mutation. Also, you should not be suitable for the strongest types of chemotherapy.

Before joining, you might have already received one cycle of treatment with Venetoclax and Azacitidine, which is acceptable. However, if your AML has come back after treatment, or if you've had other types of AML treatment (except for certain specific medications like Hydroxyurea or one cycle of Venetoclax and Azacitidine as standard care), you likely wouldn't be able to join.

There are also other reasons you might not be able to participate. For instance, if you've previously taken Gilteritinib, or if your cancer has spread to your brain or spinal cord. Certain heart conditions or taking particular herbal remedies (like St. John's wort) would also prevent you from joining. The study is open to adults aged 18 and over, of any gender.

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.

I have been newly diagnosed with AML.
My AML has a FLT3 mutation.
My doctor has said I am not suitable for intensive chemotherapy.
I am 18 years old or older.
I have not had Gilteritinib before.
I do not have specific heart problems or other conditions that would prevent me from joining.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the combination treatment of Gilteritinib, Venetoclax, and Azacitidine. The doctors will closely monitor how you react to the medication and how well it is working. This will involve regular check-ups, blood tests, and possibly other tests to assess your health and the effects of the treatment. The main goal is to find the safest and most effective dose for patients with your specific condition. The total duration of your participation, including follow-up, would be discussed in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close medical supervision. However, there are also potential risks, including side effects from the medications, which might be unknown or different from standard treatments. The medical team will explain all known side effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Technische Universität Dresden
Verified postcode
Dresden, Germany· Recruiting

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia, a type of cancer that affects the blood and bone marrow, where your body makes new blood cells.

What is a FLT3 mutation?

A FLT3 mutation is a specific change found in the genes of some people with AML. It affects how the cancer behaves and can influence treatment choices.

What does 'ineligible for intensive treatment' mean?

This means that for various health reasons, the strong, intensive chemotherapy usually given for AML might not be suitable or safe for you.

Are the study drugs new?

Gilteritinib is a newer drug, while Venetoclax and Azacitidine are established treatments often used for AML.

How long will the study last?

The exact duration of your participation would be explained by the study team, including how long you would receive treatment and how long you would be followed up.

How to find out more

Prof. Dr. Christoph Röllig, MD, MSc

sequence@ukdd.de +49 351 458 4190 Official trial record

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