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

An Open-Label Phase I/II Study of Relatlimab (BMS-986016) with Nivolumab (BMS-936558) in Combination with 5-Azacytidine for Relapsed/Refractory Acute Myeloid Leukemia and in Combination with 5-Azacytidine and Venetoclax for Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Negative for NPM1 and IDH 1/2 Mutations Who Are Ineligible for Intensive Chemotherapy (AARON)

This study, called AARON, is investigating new drug combinations for Acute Myeloid Leukaemia (AML). It's split into two parts: finding the safest dose (Phase I) and then checking how well the treatments work (Phase II). Researchers are testing combinations involving relatlimab, nivolumab, 5-azacytidine, and sometimes venetoclax. They are looking at two groups of patients: those whose AML has returned or hasn't responded to previous treatment, and newly diagnosed patients who are not suitable for intensive chemotherapy. The main goals are to find the right dose, see how many patients respond to the treatment, and understand any side effects. This research hopes to find better ways to treat AML.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Klinikum der Universitaet Muenchen AöR

Enrolment target

Start

02 Oct 2024

Acute Myeloid Leukemia

What is this study about?

This clinical trial, known as AARON, is exploring new ways to treat a type of blood cancer called Acute Myeloid Leukaemia (AML). AML affects the blood and bone marrow, and it can be a challenging disease to treat. The study is investigating specific combinations of medications that haven't been widely used together in this way before.

The trial is looking at two main groups of people with AML. The first group includes patients whose AML has either come back after previous treatment (relapsed) or hasn't responded to earlier treatments (refractory). The second group consists of people who have been recently diagnosed with AML but are unable to undergo very strong chemotherapy due to their age or other health conditions. Importantly, for these newly diagnosed patients, the study is focusing on those whose AML cells do not have specific genetic changes called NPM1 and IDH 1/2 mutations.

The researchers are combining several drugs: relatlimab, nivolumab, 5-azacytidine (also known as Vidaza), and in some cases, venetoclax. The study has two main steps. First, they need to figure out the safest and most effective dose of these drug combinations. This is called the 'Phase I' part. Once they've found the right dose, they will move to 'Phase II' to see how many patients respond to the treatment and how well it works overall. They will also be carefully monitoring any side effects to understand the safety of these new approaches.

Key takeaways

This study is testing new drug combinations for AML.
It aims to find safe doses and see how well the treatments work.
It includes patients whose AML has returned or hasn't responded to previous treatments.
It also includes newly diagnosed patients who cannot have strong chemotherapy.
Careful monitoring for safety and effectiveness is a key part of the study.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. This research is open to both men and women.

The study is specifically for people diagnosed with Acute Myeloid Leukaemia (AML). It includes two different groups of patients: those whose AML has returned after treatment or hasn't responded to previous treatments, and those newly diagnosed with AML but are not able to have intensive chemotherapy. If you are in the newly diagnosed group, your AML will also need to be checked for specific genetic markers (NPM1 and IDH1/2 mutations) and found to be negative for these.

There will be other detailed medical criteria that your doctor will check to see if this study is suitable for you. These criteria help make sure the study includes the right people for whom the treatment might be most helpful and safest, and also ensure the results are clear.

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 Leukaemia (AML)?
Has your AML come back or not responded to previous treatments, OR have you been newly diagnosed and cannot have strong chemotherapy?
If newly diagnosed, has your AML been tested and found NOT to have NPM1 or IDH 1/2 gene changes?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic for assessments. You would receive the study medications, which are given through different methods, potentially including injections and infusions. Throughout your time in the study, doctors and nurses would closely monitor your health, take blood tests, and perform other examinations to see how you are responding to the treatment and to check for any side effects.

The study would start by carefully finding the right dose of the combined medications. Once the dose is established, you would continue with that treatment as long as it is helping you and you are tolerating it well. The total length of your participation would depend on how your disease responds and your ability to continue the treatment, as well as the study's overall schedule. There would also be follow-up appointments after you finish the treatment period.

Potential risks and benefits

Participating in this study might offer potential benefits, as you would be trying new drug combinations that could be more effective than standard treatments for your AML. However, there's no guarantee that the treatment will work for everyone. Like all medications, the drugs used in the study have potential side effects, and these could range from mild to serious. The research team will carefully monitor you for any side effects and manage them as best as possible. You are always free to leave the study at any time, for any reason, without it affecting your usual 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
Germany

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that starts in the bone marrow, the soft inside part of bones where new blood cells are made. It causes too many unhealthy white blood cells to be produced.

What does 'relapsed/refractory' mean?

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

Why are they looking at patients who 'cannot have intensive chemotherapy'?

Some people might be too unwell or too old for very strong chemotherapy. This study is looking for gentler but still effective treatment options for them.

What are 'NPM1 and IDH 1/2 mutations'?

These are specific genetic changes that can be found in AML cells. This study is specifically looking at patients who do NOT have these changes for the newly diagnosed group.

What are 'Phase I' and 'Phase II' of a study?

Phase I trials mainly check if a new treatment is safe and help find the right dose. Phase II trials then see if the treatment works well for the disease.