RecruitingPHASE1INTERVENTIONAL

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

This study is investigating a new medication called SNDX-5613 when given alongside intensive chemotherapy for adults recently diagnosed with Acute Myeloid Leukemia (AML). The main goal is to find the safest and most effective dose of SNDX-5613. Researchers will also check how well the new drug works and if it causes any side effects. This treatment is specifically for people whose AML has certain genetic changes (KMT2A, NPM1, or NUP98 mutations). Understanding these new combinations could lead to better treatments for AML in the future, offering hope to patients with these particular types of AML.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Syndax Pharmaceuticals

Enrolment target

Start

21 May 2024

Estimated completion

01 Feb 2027

Acute Myeloid Leukemias

What is this study about?

This study is focused on a type of blood cancer called Acute Myeloid Leukemia (AML). When someone has AML, their body makes too many abnormal white blood cells, which can stop healthy blood cells from doing their job. Standard treatment often involves strong chemotherapy, but researchers are always looking for ways to make treatments better and more effective, especially for people with specific types of AML.

This particular study is testing a new drug called SNDX-5613. It's being given in combination with the intensive chemotherapy that patients with AML usually receive. The scientists want to find out if adding SNDX-5613 makes the treatment more successful and if it's safe for patients. They are especially interested in patients whose AML has certain genetic changes, which doctors call KMT2A, NPM1, or NUP98 alterations. These specific changes mean the AML might respond differently to treatments, so targeting them could be important.

Initially, the study will involve a small group of patients to figure out the best and safest dose of SNDX-5613 when combined with chemotherapy. After that, more patients will join to further confirm the safety and see how well the treatment works. The treatment journey typically includes an initial phase to get the cancer under control, a consolidation phase to clear remaining cancer cells (which might include a stem cell transplant for some), and finally, a maintenance phase where patients take only SNDX-5613 for a period. Each treatment cycle is planned to last 28 days.

Key takeaways

This study is testing a new drug (SNDX-5613) with standard chemotherapy.
It's for adults, aged 18-75, newly diagnosed with specific types of AML.
The AML must have certain genetic changes (KMT2A, NPM1, or NUP98).
Aims to find the safest dose and see how well the new treatment works.
Includes initial treatment, consolidation, and a maintenance phase with the new drug.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 75 years old and have been recently diagnosed with Acute Myeloid Leukemia (AML). Crucially, your AML must have specific genetic changes that doctors look for: KMT2A, NPM1, or NUP98 mutations. You also need to be fit enough to receive intensive chemotherapy, and your general health, including your heart, liver, and kidney function, should be good.

There are certain reasons why someone might not be able to join. For example, if you have a different type of leukaemia called acute promyelocytic leukaemia, or if your AML has spread to your brain or spinal cord. Other reasons include specific heart problems, certain ongoing infections, serious gut issues that might stop the drug from working, or if you have severe liver disease. You also can't be pregnant or breastfeeding. The medical team will check all these details carefully to make sure the study is right and safe 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 between 18 and 75 years old?
Have you recently been diagnosed with Acute Myeloid Leukemia (AML)?
Has your doctor tested your AML for KMT2A, NPM1, or NUP98 genetic changes?
Are you generally well enough to receive strong chemotherapy treatments?
Are you NOT currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new drug SNDX-5613 along with standard intensive chemotherapy. The study usually involves different stages: an initial treatment phase, a phase to consolidate the treatment (which might include a stem cell transplant if suitable), and then a longer phase where you take only the new drug as a maintenance treatment. Each stage involves regular hospital visits for treatments, blood tests, and check-ups to monitor your health and how you're responding. You will have regular appointments with the study doctors and nurses who will monitor you closely for any side effects and to see how the treatment is working. The overall duration of your participation will depend on your response to treatment and the study plan, but each treatment cycle is 28 days long.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment that isn't widely available yet, which could be more effective for your specific type of AML. However, there are also potential risks; new drugs can have unexpected side effects, and the combination treatment might cause more severe side effects than standard chemotherapy alone. The study doctors will explain all known and possible risks in detail. It's important to remember that joining a clinical study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (46)

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

UCLA Medical Hematology
Verified postcode
Burbank, United States· Recruiting
City of Hope Medical Center
Verified postcode
Duarte, United States· Recruiting
AdventHealth Blood & Marrow Transplant Center
Verified postcode
Orlando, United States· Recruiting
Tampa General Hospital
Verified postcode
Tampa, United States· Recruiting
Emory Winship Cancer Institute
Verified postcode
Atlanta, United States· Recruiting
University of Chicago
Verified postcode
Chicago, United States· Recruiting
University of Louisville Health Brown Cancer Center
Verified postcode
Louisville, United States· Recruiting
Norton Cancer Institute, St. Matthews Campus
Verified postcode
Louisville, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Allina Health Cancer Institute
Verified postcode
Minneapolis, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting

Common questions

What is Acute Myeloid Leukemia (AML)?

AML is a type of cancer that affects the blood and bone marrow, where new blood cells are made. It causes the body to produce too many abnormal white blood cells.

What does 'intensive chemotherapy' mean?

Intensive chemotherapy uses strong medicines to kill cancer cells throughout the body. It's a common treatment for AML but can have significant side effects.

What are genetic 'alterations' or 'mutations'?

These are small changes in the DNA of your cancer cells. For this study, particular changes (like KMT2A, NPM1, or NUP98) are important because the new drug might target them.

Is SNDX-5613 a chemotherapy drug?

SNDX-5613 is a new investigational drug that works differently from traditional chemotherapy. In this study, it's given alongside standard chemotherapy.

What is a 'stem cell transplant'?

A stem cell transplant involves replacing unhealthy blood-forming cells with healthy ones. It's a common treatment option for some AML patients after chemotherapy.

How to find out more

Syndax Pharmaceuticals

clinicaltrials@syndax.com 781-419-1400 Official trial record

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