Study of Ivosidenib or Enasidenib with Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome with IDH1 or IDH2 Mutation
This clinical trial is focused on studying treatments for patients who have been newly diagnosed with either acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). These are types of blood cancers that affect the bone marrow, where blood cells are made. The study is specifically for patients whose cancer cells have a mutation in the IDH1 or IDH2 genes. These mutations can affect how the cancer grows and responds to treatment.
The trial will test two medications, ivosidenib and enasidenib, which are taken as film-coated tablets. These medications are designed to target the specific gene mutations in the cancer cells. The study will compare the effects of these medications when used alongside standard chemotherapy treatments. Some patients will receive a placebo instead of the active medication to help researchers understand the true effects of the drugs being tested.
The purpose of the study is to see if these treatments can improve the time patients live without the cancer getting worse, known as event-free survival. Participants will go through different phases of treatment, including induction therapy, consolidation therapy, and maintenance therapy. These phases are designed to first reduce the number of cancer cells, then stabilize the condition, and finally maintain the results over time. The study aims to provide valuable information on how effective these treatments are for patients with these specific gene mutations in AML or MDS.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical condition, and genetic markers.
Informed consent is required to participate in the study.
2induction therapy
Induction therapy involves the administration of chemotherapy combined with either ivosidenib or enasidenib.
Ivosidenib is provided as a 250 mg film-coated tablet for oral use.
Enasidenib is provided as a 100 mg film-coated tablet for oral use.
The goal of this phase is to achieve remission of the disease.
3consolidation therapy
Following successful induction therapy, consolidation therapy is administered to maintain remission.
This phase also involves the use of ivosidenib or enasidenib in combination with chemotherapy.
4maintenance therapy
Maintenance therapy is provided to prevent relapse after achieving remission.
This phase continues the administration of ivosidenib or enasidenib.
5monitoring and follow-up
Throughout the study, regular monitoring is conducted to assess the effectiveness of the treatment and any side effects.
Follow-up visits are scheduled to evaluate overall health and disease status.
Who Can Join the Study?
Must be at least 18 years old.
If female, must either be unable to have children (postmenopausal or surgically sterile) or agree to use effective birth control and not become pregnant during the study and for 6 months after the last study drug. Must also have a negative pregnancy test before starting the study, not breastfeed during the study and for 2 months and 1 week after, and not donate eggs during the study and for 6 months after.
If male, must use effective birth control with female partners who can have children during the study and for 4 months and 1 week after the last study drug. Must also not donate sperm during the study and for 4 months and 1 week after.
Must agree not to join another study while receiving treatment in this one.
Must have newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS-EB2) with a specific gene mutation (IDH1 or IDH2). If AML is due to previous blood disorders or treatments, these must have been present for at least 3 months. Previous treatment with certain drugs for MDS must have stopped at least four weeks before joining.
If having both FLT3 and IDH1 or IDH2 mutations, can join only if not suitable for FLT3 inhibitor treatment for medical or other reasons.
Must be eligible for strong chemotherapy treatment.
Must have a performance status of 2 or less, which means being able to carry out all self-care but unable to do any work activities.
Must have adequate liver function, shown by specific blood test results, unless certain conditions apply.
Must have adequate kidney function, shown by a creatinine clearance greater than 40 mL/min.
Must be able to understand and willing to sign a consent form agreeing to participate in the study.
Must provide written informed consent.
Who Cannot Join the Study?
Patients who do not have a newly diagnosed condition of either acute myeloid leukemia (a type of blood cancer) or myelodysplastic syndrome (a group of disorders caused by poorly formed or dysfunctional blood cells).
Patients who do not have an IDH1 or IDH2 mutation. These are specific changes in genes that can affect how cells grow.
Patients who are not eligible for intensive chemotherapy, which is a strong treatment using drugs to kill cancer cells.
Patients who are outside the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Ivosidenib is a medication used in this trial for patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who have a specific genetic mutation called IDH1. It is given in combination with other treatments to help improve the chances of survival without the disease getting worse.
Enasidenib is another medication used in the trial for patients with the same conditions but with a different genetic mutation called IDH2. Like ivosidenib, it is used alongside other therapies to help manage the disease and improve outcomes for patients.
Acute myeloid leukemia – Acute myeloid leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses quickly and requires prompt medical attention. It is more common in older adults but can occur at any age. AML is classified into different subtypes based on genetic and chromosomal abnormalities.
Myelodysplastic syndrome – Myelodysplastic syndrome (MDS) is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when the blood-forming cells in the bone marrow are damaged, leading to a shortage of one or more types of blood cells. Symptoms may include fatigue, shortness of breath, and increased risk of bleeding or infection. MDS can progress slowly or transform into acute myeloid leukemia in some cases. The condition is more prevalent in older adults and can vary in severity. MDS is often detected through routine blood tests showing abnormal blood cell counts.
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