Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase I/II Study of NMS-03592088, a FLT3, KIT and CSF1R Inhibitor, in Patients with Relapsed or Refractory AML or CMML

This research study is about a new drug called NMS-03592088. It's being tested in adults (aged 18 and over) who have Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML). These are types of blood and bone marrow cancers. The study is for patients whose cancer has either returned after treatment or didn't get better with previous treatments. The main goals are to find out how safe the new drug is and to see what dose works best without causing too many side effects (this is the Phase I part). Later, in Phase II, the study will look at how well the drug helps patients, especially those with a specific change in their AML called FLT3-ITD, by checking if their cancer goes into remission.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Nerviano Medical Sciences S.r.l., Nerviano Medical Sciences S.r.l.

Enrolment target

143

Start

14 Dec 2023

Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia(CMML) relapsed or refractory

What is this study about?

This study is a clinical trial testing a new medicine called NMS-03592088. It's designed for people who have been diagnosed with two specific types of blood cancer: Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML). These are cancers that affect the blood and bone marrow. The study is particularly for patients whose cancer has either returned after they've had treatment, or for those whose cancer didn't improve with the treatments they've already tried.

Clinical trials are done in different stages, called 'phases'. This study is an 'integrated Phase I/II' trial, which means it combines two stages. In Phase I, the main aim is to find the safest dose of the new drug and understand its side effects. This is the very first time this drug is being given to people. Once a safe dose is found, the study moves into Phase II. In this phase, the main goal is to see how well the drug works, especially for a certain type of AML with a specific genetic change (called FLT3-ITD). The researchers will be looking to see if patients experience a 'complete remission' or a 'complete remission with incomplete blood count recovery', which are ways medical professionals describe when the cancer cells are greatly reduced or disappear.

The reason this study matters is that it's looking for new and potentially better ways to treat AML and CMML, especially when current treatments haven't worked or when the cancer has come back. Finding new medicines that can help slow down or stop the growth of these cancers, or even lead to remission, is really important for patients and their families. While it's a new drug, studies like this are a vital step in developing new treatments that could improve the lives of many people.

Key takeaways

This study is testing a new drug for specific blood cancers (AML, CMML) that have returned or are resistant to treatment.
It's an early-stage study, first checking for safety and then how well the drug works.
Participation involves taking the new medicine and having regular check-ups and tests.
There are potential benefits and risks, like with any new treatment, and you can withdraw at any time.
The study aims to find new options for challenging cases of AML and CMML.

Who may be eligible?

To join this study, you would need to be 18 years old or older. The study is open to both men and women. The most important health conditions for joining are a diagnosis of Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML). Importantly, your cancer must have either come back after you've had treatment for it, or it must not have responded well to the treatments you've tried in the past.

There might be other health requirements or conditions that mean you can't take part, even if you have AML or CMML. These could include other serious health problems, or if you've recently had certain other treatments. The medical team running the study will check all these details carefully.

Your doctor will be able to help you understand if your specific situation matches what the study is looking for. It's always best to discuss your full medical history with them to see if this study could be an 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.

Are you 18 years old or older?
Have you been diagnosed with Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML)?
Has your cancer come back after treatment, or did it not respond to previous treatments?
Are you able to visit the hospital or clinic regularly for appointments and tests?
Are you willing to take a new experimental medicine?
Have you discussed this study with your current doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the new medicine, NMS-03592088, according to a schedule set by the study doctors. You will have regular visits to the hospital or clinic. These visits will involve various tests, such as blood tests, urine tests, and sometimes bone marrow biopsies, to check how you are responding to the medicine and to monitor any side effects. You'll also be regularly checked by the study doctors and nurses to track your general health. The exact number and frequency of visits, as well as the total duration of your participation, will depend on which phase of the study you are in and how you respond to the treatment. It's important to remember that all these tests and assessments are done to ensure your safety and to see if the medicine is working.

Potential risks and benefits

Like all medicines and medical studies, there are potential benefits and potential risks to consider. A potential benefit of joining this study is that you might receive a new treatment that could help your AML or CMML, especially if other treatments haven't worked. However, because this is a new medicine, there's no guarantee it will work for everyone, and it might not work for you. There is always a risk of side effects with any new drug, some of which could be serious. The study team will monitor you very closely for any side effects and will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Spain
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Unverified
Italy

Common questions

What kind of cancers is this study for?

This study is for two types of blood cancer: Acute Myeloid Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML). Specifically, it's for cases where the cancer has returned or didn't respond to previous treatments.

What does 'Phase I/II' mean?

Phase I means it's the first time the new drug is given to people, mainly to find a safe dose and look for side effects. Phase II looks at how well the drug works and continues to check for side effects.

What is the new medicine called?

The new medicine being tested in this study is called NMS-03592088.

Will I definitely get better if I join this study?

There's no guarantee that anyone will get better. This is a research study to see if the medicine works and is safe. The aim is to find better treatments in the future.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time without having to give a reason. This will not affect your regular medical care.