Active not recruitingPHASE2INTERVENTIONAL

A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

This study is for adults with a type of blood cancer called Acute Myeloid Leukaemia (AML) that has come back or not responded well to previous treatments. Specifically, it's for those whose AML has a particular gene change (FLT3-ITD or FLT3-TKD mutation). The study is testing a new combination of medicines: gilteritinib, gemtuzumab ozogamicin, and cytarabine. Gilteritinib is a newer drug that targets the FLT3 gene. Researchers want to find out if this new combination is safe and effective in treating this specific type of AML. It's a 'Phase 2' study, meaning they are looking closely at how well the treatment works and its side effects.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Centre Antoine Lacassagne

Enrolment target

Start

03 Jun 2023

Estimated completion

10 Jul 2028

AML Leukaemia (Acute Myeloid)

What is this study about?

This study is for adults who have a type of blood cancer called Acute Myeloid Leukaemia (AML). AML is a cancer of the blood and bone marrow, which are responsible for making blood cells. Sometimes, AML can be difficult to treat, especially if it comes back after treatment (this is called 'relapsed' AML) or if it doesn't respond to initial treatments ('refractory' AML).

Researchers are particularly interested in patients whose AML has a specific change in a gene called 'FLT3'. This change, called a mutation (FLT3-ITD or FLT3-TKD), can make the cancer grow or spread. This study is testing a new way to treat this kind of AML by combining existing treatments with a newer drug called gilteritinib. Gilteritinib works by targeting the FLT3 gene change.

The study combines gilteritinib with two other medicines already used to treat AML: gemtuzumab ozogamicin and cytarabine. The main goal is to see if this new combination is safe and if it can effectively shrink or control the leukaemia. It's a 'Phase 2' study, which means researchers are checking how well the treatment works and any side effects it might cause, in a relatively small group of people.

Key takeaways

This study is for adults with specific types of AML that have come back or not responded to treatment.
It's testing a new combination of three drugs, including a targeted therapy called gilteritinib.
The main goals are to check the combination's safety and effectiveness.
Participation involves regular hospital visits, treatments, and close monitoring.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with AML that has either come back or not responded to previous treatments. Your AML must show a specific marker called CD33, and also have a particular gene change (FLT3-ITD or FLT3-TKD mutation).

You might be eligible if your AML didn't get better after one or two rounds of strong chemotherapy, or after other specific treatments. You could also be eligible if your AML came back after your first round of treatment. Even if you've had other FLT3-targeting drugs before (but not gilteritinib), you might still be able to join. Your general health, including how well your liver and kidneys are working, also needs to be within certain limits.

However, you will *not* be able to join if you have a different specific type of AML (like acute promyelocytic leukaemia or AML with a BCR-ABL1 gene change), or if your AML developed from certain other blood conditions. You also can't participate if the cancer has spread into your brain or spinal cord, or if you've had a stem cell transplant in the last six months.

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?
Has your AML come back or not responded to previous treatment?
Does your AML have a FLT3-ITD or FLT3-TKD gene change?
Are your liver and kidney functions generally healthy?
Have you *not* had certain other types of AML or recent stem cell transplants?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the combination of three medications: gilteritinib, gemtuzumab ozogamicin, and cytarabine. The study involves regular hospital visits for treatments, blood tests, and check-ups to monitor your health and the effect of the treatment. You will be closely monitored for any side effects. The exact number of visits and the total duration in the study will depend on how your body responds to the treatment and will be explained in detail by the study team. You would also have regular scans or tests to see how the leukaemia is responding.

Potential risks and benefits

Taking part in this study may offer potential benefits, as you would be receiving an experimental combination therapy that might be more effective for your specific type of AML than standard treatments. However, like all medical treatments, there are potential risks, including side effects from the medications. The doctors and nurses will explain these thoroughly, and you will be closely monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

CHU d'Amiens
Verified postcode
Amiens, France
CHU d'Angers
Verified postcode
Angers, France
CHU Bordeaux
Verified postcode
Bordeaux, France
CHU de Caen
Verified postcode
Caen, France
CHMS de Chambery
Verified postcode
Chambéry, France
HIA Percy
Verified postcode
Clamart, France
CHU Limoges
Verified postcode
Limoges, France
CHRU Nancy
Verified postcode
Nancy, France
Centre Hospitalier Universitaire de Nice
Verified postcode
Nice, France
Hôpital Saint Louis
Verified postcode
Paris, France
Centre Henri Becquerel
Verified postcode
Rouen, France
Centre Hospitalier de Versailles
Verified postcode
Versailles, France

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 blood cells are made.

What is a 'relapsed' or 'refractory' AML?

Relapsed means the cancer has come back after treatment. Refractory means the cancer did not respond to initial treatments.

What is a 'FLT3 mutation'?

It's a specific change in a gene within the leukaemia cells. This change can affect how the cancer grows and tell doctors if certain targeted medicines might work well.

What does 'Phase 2' mean for a study?

In a Phase 2 study, researchers are looking closely at how effective a new treatment or combination is, and further checking its safety, in a specific group of patients.

Will I have to pay for the treatment?

No, if you're eligible and agree to take part in this study in France, your treatment and care related to the study will be covered, including costs typically covered by National Health Insurance.