Recruiting

A study to evaluate the safety and efficacy of ivosidenib, decitabine, and cedazuridine in adults with newly diagnosed acute myeloid leukemia who are older than 60 or cannot receive intensive chemotherapy.

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the safety and effectiveness of a combination of two medications for adults with Acute Myeloid Leukemia. This is a type of blood cancer that affects the production of white blood cells in the bone marrow. The study focuses on patients who have a specific genetic change known as an IDH1 mutation, which is a mistake in the DNA that causes cancer cells to grow. The treatment being tested involves taking two drugs, ivosidenib and decitabine combined with cedazuridine, by mouth in the form of tablets.

The research is designed for individuals who have been newly diagnosed with this cancer and are either older than 60 years of age or cannot undergo standard induction chemotherapy, which is the intensive initial treatment used to kill cancer cells. Participants in the study will take the oral medications as part of their treatment plan to see how well the drugs work to achieve a complete response, meaning the cancer cells are no longer detectable, and to monitor any side effects that may occur.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Treatment starts with the administration of two oral medications: ivosidenib (brand name tibsovo) and a combination of decitabine and cedazuridine (brand name inaqovi).
The ivosidenib dosage is 500 mg taken by mouth.
The decitabine and cedazuridine dosage is 135 mg taken by mouth.
Step 2
Monitoring and evaluation
The process focuses on evaluating the safety and efficacy of the medication combination.
efficacy is measured by checking for a complete response (cr) or an immunophenotypic complete response (cri), which are terms used to describe the disappearance of leukemia cells from the blood and bone marrow.
Additional observations include tracking overall survival and event-free survival.

Who can join the trial?

12 criteria

You must have a new diagnosis of acute myeloid leukemia, which is a type of cancer that affects the blood and bone marrow.
You must have a specific genetic change in your cancer cells called an IDH1 R132 mutation.
You must be at least 60 years old, or if you are between 18 and 60 years old, you must have other health conditions that prevent you from receiving intensive chemotherapy.
If you are under 70 years old and have a type of leukemia considered low risk, you can only join if you are not a candidate for standard intensive chemotherapy.
You must be able to perform daily activities according to your age; this is measured by a scale called ECOG performance status, which rates how much your illness affects your ability to function.
Your kidney function must be healthy, measured by how well your kidneys filter waste (creatinine clearance).
Your liver function must be within safe limits, specifically looking at levels of AST, ALT, and bilirubin, which are substances measured in blood tests to check liver health.
Your white blood cell count, which are cells that help fight infection, must be less than 30 x 10^9/L.
Women who can become pregnant must use specific birth control methods and have a negative pregnancy test.
Women who have gone through menopause (the end of menstrual cycles) or have had surgery to prevent pregnancy are also eligible.
Men who are sexually active must agree to use contraception (methods to prevent pregnancy) during the study and for 90 days after the last dose.
You must voluntarily sign an informed consent form, which is a document that explains all the study details before any tests begin.

Who cannot join the trial?

15 criteria

You have a history of myeloproliferative neoplasm (a type of blood cancer where the body makes too many abnormal blood cells) that includes a specific genetic change called BCR-ABL1 translocation, or you have acute myeloid leukemia with that same genetic change.
Your liver function is poor, which is measured by high levels of AST, ALT (enzymes that show liver health), or bilirubin (a yellow substance produced when red blood cells break down), unless this is caused by the leukemia itself.
Your white blood cell count (the number of cells in your blood that fight infection) is higher than 30 x 10⁹/L and cannot be lowered using specific medications.
You have any medical reason that makes it unsafe for you to take IVO or oral decitabine based on the official Summary of Product Characteristics (the official document containing information for healthcare professionals about how to use the medicine).
You have a heart rate-corrected QT interval (a measurement of the time it takes for your heart muscle to recharge between beats) that is 450 milliseconds or longer, or you have conditions that increase the risk of arrhythmia (irregular heart rhythms), such as hypokalemia (low potassium levels in the blood) or a family history of long QT interval syndrome.
You have previously received treatment for acute myeloid leukemia, other than the medication hydroxyurea.
You have been genetically diagnosed with acute promyelocytic leukemia (a specific subtype of leukemia).
You are known to be positive for HIV (a virus that attacks the body's immune system).
You are known to have hepatitis B or hepatitis C (infections that cause liver inflammation), unless your viral load (the amount of virus in your blood) has been undetectable for at least 3 months.
You have a chronic lung disease that requires you to use continuous oxygen.
You have significant history of diseases involving the kidneys (renal), nervous system (neurologic), mental health (psychiatric), hormones (endocrinologic), body processes (metabolic), immune system (immunologic), liver (hepatic), or heart (cardiovascular).
You have a known hypersensitivity (an allergic reaction) to any of the study medicines or their excipients (inactive ingredients used to make the medicine).
You have any severe, uncontrolled systemic infection (an infection spreading throughout the entire body).
You have had other malignancies (cancerous tumors) within the last year that are not controlled or require active treatment that might interfere with the study drugs.
Your creatinine clearance (a measure of how well your kidneys filter waste from your blood) is less than 25 mL/min.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran Canaria, Spain
Hospital Pedro Hispano
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Matosinhos, Portugal
Hospital Universitario 12 De Octubre
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Madrid, Spain

Trial locations

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Investigated drugs

Ivosidenib
is a medication taken by mouth that targets a specific change in certain cells to help treat certain types of blood cancer.
Decitabine
and Cedazuridine are used together in a pill taken by mouth to help treat patients with acute myeloid leukemia by affecting how the cancer cells grow and function.

What is already known about the treatment

Ivosidenib
This medication is taken by mouth in the form of a film-coated tablet. It is an approved treatment used specifically for certain types of blood cancer that have a specific genetic change called an IDH1 mutation. As a targeted therapy, it works by blocking a specific enzyme inside cancer cells to stop them from growing and multiplying.
Decitabine and Cedazuridine
This combination is administered orally through film-coated tablets. Decitabine is an established medicine used to treat blood cancers, and it is paired here with cedazuridine, which is a substance used to help the body absorb the main drug more effectively. This combination works by interfering with the way cancer cells copy their DNA, which prevents the cancer cells from dividing and spreading.

Investigated diseases

Acute myeloid leukemia - This is a type of cancer that affects the blood and bone marrow. It occurs when the body produces an abnormal number of immature white blood cells. These abnormal cells do not function properly and crowd out healthy blood cells. As the disease progresses, the buildup of these cells interferes with the production of red blood cells, platelets, and functional white blood cells. This imbalance disrupts the normal components of the blood.