RecruitingPHASE3INTERVENTIONAL

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

This research study is looking at a new medicine called mocravimod for adults with a type of blood cancer called Acute Myeloid Leukaemia (AML). Patients taking part will be having a stem cell transplant, also known as an allogeneic hematopoietic cell transplant. The study wants to find out if mocravimod, given alongside and after the transplant, is effective and safe. The main goal is to see if it can help prevent the cancer from returning and improve the chances of a successful transplant. It's a carefully designed study where some patients will receive mocravimod and others a dummy medicine (placebo) to fairly compare the results.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Priothera SAS

Enrolment target

366

Start

16 Jun 2022

Estimated completion

01 Nov 2029

Adult Acute Myeloid Leukemia

What is this study about?

This study is investigating a new medicine called mocravimod for adults who have acute myeloid leukaemia (AML). AML is a type of cancer that affects the blood and bone marrow. For many patients with AML, a stem cell transplant (also known as an allogeneic hematopoietic cell transplant) is an important part of their treatment. This transplant involves replacing a person’s diseased bone marrow with healthy blood-forming stem cells from a donor.

The purpose of this particular study is to see if adding mocravimod to the standard treatment plan – both alongside and after the stem cell transplant – can improve how well patients do. Researchers want to find out if this new medicine can help prevent the AML from coming back and whether it is safe for patients to use during this critical time. Because it's a new medicine, it's really important to carefully check both its benefits and any potential side effects.

To make sure the results are fair and reliable, this study is 'randomised', meaning patients will be randomly put into groups, with some receiving mocravimod and others a 'dummy' medicine (placebo). It's also 'double-blinded', which means neither the patients nor their doctors will know who is getting the study medicine and who is getting the placebo. This helps to make sure there's no bias in the results.

Key takeaways

This study is for adults with AML having a stem cell transplant.
It's testing a new medicine called mocravimod to help prevent cancer return.
The study is 'double-blinded' and 'randomised' for fair results.
Participation involves regular checks and potentially a new medicine or a placebo.
You can stop participating at any time if you wish.

Who may be eligible?

This study is for adults generally aged between 18 and 75 who have been diagnosed with a specific type of acute myeloid leukaemia (AML). Your AML must be in remission (meaning the cancer cells are not detectable) and you must be planning to have a stem cell transplant from a suitable donor. Your general health, including heart, lung, kidney, and liver function, will need to be good, and your day-to-day activities shouldn't be too limited by your health.

There are certain reasons why you might not be able to join the study. For example, if your AML is a very rare type of promyelocytic leukaemia, or if you have specific eye conditions like macular oedema or uveitis. Also, if you have certain health problems like poorly controlled diabetes or significant issues with your heart, lungs, liver, or kidneys, you may not be able to take part. Some specific medicines that are sometimes used to prevent transplant complications, like ciclosporin (CsA) or certain antibodies, would also mean you couldn't join this study.

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 an adult aged 18 to 75?
Do you have Acute Myeloid Leukaemia (AML) that is currently in remission?
Are you planning to have a stem cell transplant from a suitable donor?
Does your doctor consider your heart, lung, liver, and kidney health generally good?
Do you *not* have specific eye conditions like macular oedema or uveitis?
Are you able to perform most of your daily activities without significant difficulty?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication (mocravimod or a placebo) for a period alongside and after your stem cell transplant. This will involve regular visits to the hospital for checks, blood tests, and other assessments to monitor your health and how the treatment is working. Doctors will carefully track any side effects you might experience. The total length of your participation in the study, including follow-up visits, will be explained in detail by the study team, but typically these kinds of trials involve monitoring over several months to a few years.

Potential risks and benefits

Taking part in this study might offer a potential benefit if mocravimod helps to prevent your AML from returning or improves your transplant outcome, though it's important to remember that it's a new medicine and we don't yet know for sure how effective it will be. There are also potential risks, as with any new medicine, including unknown side effects. The study team will carefully monitor you for any problems. You will be given full information about known risks, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (108)

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

University of Alabama Hospital (UAB Hospital)
Verified postcode
Birmingham, United States· Recruiting
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Withdrawn
City of Hope Comprehensive Cancer Center - Duarte
Verified postcode
Duarte, United States· Recruiting
University of California Los Angeles (UCLA) - David Geffen School of Medicine
Verified postcode
Los Angeles, United States· Recruiting
UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
Verified postcode
Aurora, United States· Withdrawn
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Emory University - Winship Cancer Institute (WCI)
Verified postcode
Atlanta, United States· Recruiting
University of Iowa Hospitals and Clinics
Verified postcode
Iowa City, United States· Recruiting
University of Kansas Cancer Center
Verified postcode
Westwood, United States· Recruiting
Ochsner Medical Center (OMC) - New Orleans
Verified postcode
New Orleans, United States· Withdrawn
University of Maryland Medical Center (UMMC)
Verified postcode
Baltimore, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Withdrawn

Common questions

What is AML?

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

What is a stem cell transplant?

A stem cell transplant (also called a bone marrow transplant) replaces unhealthy blood cells in your body with healthy ones from a donor.

What does 'randomised and double-blinded' mean?

It means you'll be randomly assigned to get either the new medicine or a dummy medicine, and neither you nor your doctor will know which one you're getting. This helps make the study fair.

Will I still get my usual care?

Yes, you will still receive all your usual care for your AML and transplant, with the study medicine being an additional part of your treatment plan.

How long will I be in the study?

The study team will explain the exact duration, which typically involves taking the medicine for a period and then having follow-up checks over several months or longer.

How to find out more

Malika Souquieres, MSc

malika.souquieres@priothera.com +33 (0) 6 40 91 26 76 Official trial record

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