This study involves patients with Acute Myeloid Leukemia, a type of blood cancer that affects the bone marrow and blood. The study focuses on patients whose leukemia has specific genetic changes, either a change in a gene called NPM1 or rearrangements involving a gene called KMT2A. The treatment being tested is JNJ-75276617, also known as bleximenib, which is given in the form of film-coated tablets taken by mouth. Some patients will receive bleximenib while others will receive placebo.
The purpose of this study is to find out if adding bleximenib to the standard intensive chemotherapy treatment can help patients live longer without their disease getting worse compared to receiving standard chemotherapy with placebo. The standard treatment includes chemotherapy to put the disease into remission, followed by additional chemotherapy to strengthen this response, and then maintenance therapy to help keep the disease under control.
During the study, patients will receive either bleximenib or placebo together with their regular intensive chemotherapy treatment. The study follows patients through the initial treatment phase aimed at achieving remission, a consolidation phase to reinforce the response, and then a maintenance phase. Neither the patients nor their doctors will know whether they are receiving bleximenib or placebo during the study. The study will monitor how well the treatment works and track patient outcomes over time.
1Randomization and treatment assignment
At the beginning of the study, you will be randomly assigned to receive either bleximenib or placebo. A placebo is an inactive substance that looks like the actual medication but contains no active ingredient.
Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study design.
The study medication will be given as film-coated tablets taken by mouth.
2Remission induction chemotherapy phase
You will receive intensive chemotherapy aimed at achieving complete remission. Complete remission means that the leukemia cells are no longer detectable in your blood and bone marrow.
During this phase, you will also receive either bleximenib tablets or placebo tablets in combination with the chemotherapy.
The study medication (bleximenib or placebo) will be available in two strengths: 50 mg and 100 mg tablets.
3Consolidation chemotherapy phase
After achieving complete remission, you will receive consolidation chemotherapy. This treatment is designed to eliminate any remaining leukemia cells and reduce the risk of the disease returning.
You will continue taking either bleximenib tablets or placebo tablets along with the consolidation chemotherapy.
4Maintenance therapy phase
Following the completion of consolidation chemotherapy, you will enter the maintenance therapy phase.
During this phase, you will continue taking either bleximenib tablets or placebo tablets by mouth.
The purpose of maintenance therapy is to help prevent the leukemia from returning.
5Monitoring and assessments
Throughout all phases of the study, your health will be closely monitored through regular medical examinations, blood tests, and bone marrow assessments.
Your kidney and liver function will be checked to ensure they are working adequately.
Your white blood cell count will be monitored. White blood cells are cells in your blood that help fight infections.
Your doctor will assess your overall physical condition using the WHO/ECOG performance status, which is a scale that measures how the disease affects your daily living abilities.
Who Can Join the Study?
You must be 18 years of age or older at the time you agree to join the study
You must have a new diagnosis of Acute Myeloid Leukemia, which is a type of blood cancer where abnormal white blood cells grow rapidly in the bone marrow. Your disease must show at least 10% blasts (immature blood cells) in your bone marrow (the soft tissue inside bones where blood cells are made) or blood
Your leukemia must have specific genetic changes: either a mutation in the NPM1 gene (a change in a specific gene) or rearrangements involving the KMT2A gene (changes in the structure of another specific gene)
Your doctor must determine that you are healthy enough to receive intensive chemotherapy, which is strong cancer treatment given through the vein
Your performance status must be 2 or less on the WHO/ECOG scale, which means you are able to care for yourself and are up and about for at least half of your waking hours
Your kidneys and liver must be working well enough before you are assigned to a treatment group
Your white blood cell count (the number of infection-fighting cells in your blood) must be less than 25 times 10 to the power of 9 per liter
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are reasons why a person cannot take part in a study, but these details were not included in the available information
This trial is studying a treatment called bleximenib for adults with a specific type of blood cancer called Acute Myeloid Leukemia, which is a cancer that affects blood cells and bone marrow
The study focuses on patients who have certain genetic changes in their cancer cells, specifically NPM1 mutation or KMT2A rearrangement, which are specific abnormalities in the cancer cells
Participants must be suitable for intensive chemotherapy, which means strong cancer-fighting medications given in high doses
Bleximenib is an investigational medication being studied in this trial. It is given in combination with standard chemotherapy during the initial treatment phase to help fight leukemia, and then continued as maintenance therapy. The purpose is to see if adding this medication to standard treatment can help prevent the cancer from coming back or getting worse in patients with certain types of acute myeloid leukemia.
Standard induction chemotherapy refers to the initial intensive treatment used to put the leukemia into remission. This means using powerful medications to kill as many cancer cells as possible and help the patient achieve a state where the disease is no longer detectable.
Consolidation chemotherapy is additional treatment given after the initial therapy to eliminate any remaining cancer cells and reduce the chance of the leukemia returning. This helps to strengthen and maintain the remission achieved with the induction treatment.
Acute Myeloid Leukemia – Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow. It occurs when the bone marrow begins to produce abnormal white blood cells called myeloblasts, which do not function properly. These abnormal cells multiply rapidly and crowd out healthy blood cells in the bone marrow. As the disease progresses, the number of normal red blood cells, white blood cells, and platelets decreases. This leads to symptoms such as fatigue, frequent infections, easy bruising, and bleeding. The condition develops quickly and requires prompt medical attention.
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