Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

AML-NET : Acute Myeloid Leukemia treated with with NETrin Abs in combination with [AZACITIDINE + VENETOCLAX]

This research study is for people who have Acute Myeloid Leukaemia (AML), a type of blood cancer, and whose current treatments haven't worked well. It's exploring a new, experimental drug called NETrin Abs. This new drug will be given alongside two medicines already used for AML: azacitidine and venetoclax. The main goal is to see if this new combination is safe and if it can help treat AML, particularly in cases where the cancer has been difficult to control. This study is in its early stages (Phase I and II), which means researchers are still learning about how the new drug works.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Leon Berard

Enrolment target

Start

25 Aug 2023

Refractory Acute Myeloïd Leukemia

What is this study about?

This clinical trial is designed for people living with a specific type of blood cancer called Acute Myeloid Leukaemia (AML). AML affects the blood and bone marrow, which is the spongy tissue inside your bones where blood cells are made. Sometimes, even after treatment, AML can be difficult to manage or might come back. When this happens, it's often called 'refractory' AML.

The study is investigating a new drug called NETrin Abs. This new medicine is being used together with two drugs that are already approved and used to treat AML: azacitidine and venetoclax. The idea is to see if adding NETrin Abs makes the treatment more effective than using azacitidine and venetoclax alone, or if it offers a new option for those whose cancer hasn't responded to previous treatments.

This trial is in its early phases (Phase I and Phase II). In Phase I, researchers are mainly focused on finding the safest dose of the new drug and understanding its side effects. Once they have a better idea of safety, Phase II will focus on whether the treatment is effective against the cancer. This combined approach helps researchers gather crucial information more quickly.

Key takeaways

Targets difficult-to-treat AML.
Uses a new experimental drug (NETrin Abs) with two existing drugs.
Aims to check safety and effectiveness.
No age or sex restrictions listed.
An early-stage clinical trial (Phase I/II).

Who may be eligible?

To join this study, you must have Acute Myeloid Leukaemia (AML) that has been difficult to treat or has not responded well to previous treatments. This is important because the study is specifically looking for new options for people in this situation.

There are no age restrictions mentioned, so adults of any age could potentially be considered. The study is open to both men and women. However, there will be other specific health requirements and tests you'll need to meet to make sure the study is safe for you and that the results will be clear.

If you have AML that hasn't responded to treatment and you're interested in learning more, your doctor can check all the full details to see if this study might be a suitable option for you.

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.

Do I have Acute Myeloid Leukaemia (AML)?
Has my AML not responded well to previous treatments, or has it come back?
Am I open to trying a new, experimental treatment combination?
Am I willing to have regular hospital visits and tests?
Have I discussed this study with my doctor?

Answer every question to see your result.

What does participation involve?

Information about what taking part involves – such as the number of visits, specific tests, taking medication, and how long you'd be followed up – is not detailed in the brief summary. However, in most clinical trials, you would typically have regular hospital visits for check-ups, blood tests, and other assessments like scans or bone marrow samples. You would receive the study drugs according to a set schedule. There would also be follow-up appointments after your treatment to monitor your health and any long-term effects. The total length of your participation would depend on the study's design and your progress, which your study doctor would explain fully.

Potential risks and benefits

Taking part in a study like this could potentially offer access to a new treatment that might help your condition, especially if other treatments haven't worked. However, new treatments can have side effects that are not fully known yet, as the study is still in its early stages. There's also no guarantee the treatment will work for you. You will be closely monitored for any side effects, and you always have the right to withdraw from the study at any time, for any reason, without affecting your regular 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 Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that starts in the blood-forming cells of the bone marrow. It causes the body to make too many abnormal white blood cells.

What does 'refractory' mean in this context?

It means the cancer has not responded to previous treatments, or it has come back after treatment.

What are azacitidine and venetoclax?

These are two medications that are already approved and used to treat AML. This study is combining them with a new drug.

What does 'Phase I and Phase II' mean?

Phase I trials check if a new drug is safe and find the right dose. Phase II trials then see if the drug works to treat the condition.

Will I get the new drug if I join?

You would receive the new drug (NETrin Abs) in combination with azacitidine and venetoclax, as this is an integrated Phase I/II study testing the combination.