This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML). The study is specifically for patients who have been newly diagnosed with a subtype of AML that does not have a certain genetic mutation known as FLT3-ITD. The main treatment being tested in this study is a medication called Quizartinib, which is taken as a film-coated tablet. Quizartinib is being compared to a placebo, which looks like the real medication but does not contain any active ingredients. The study also involves standard chemotherapy treatments, which include medications like Cytarabine, Daunorubicin, and Idarubicin, all of which are given through an intravenous infusion, meaning they are administered directly into a vein.
The purpose of the study is to see how effective Quizartinib is when used alongside these standard chemotherapy treatments. Participants will receive either Quizartinib or a placebo in combination with chemotherapy during the initial treatment phase, known as induction, and the follow-up phase, known as consolidation. After these phases, participants will continue to receive Quizartinib or placebo as a maintenance therapy for up to 36 cycles, which helps to keep the cancer from returning. The study will monitor participants over time to see how long they live and how well they respond to the treatment.
Throughout the study, participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to provide valuable information on whether adding Quizartinib to standard chemotherapy can improve outcomes for patients with newly diagnosed FLT3-ITD negative AML. This research could potentially lead to better treatment options for people with this type of leukemia.
1induction phase
The induction phase involves the administration of chemotherapy to treat acute myeloid leukemia (AML).
Medications used include daunorubicin hydrochloride and cytarabine, both administered through intravenous infusion.
The goal is to achieve a complete response (CR) or complete response with incomplete blood count recovery (CRi).
2consolidation phase
The consolidation phase begins if a complete response (CR) or CRi is achieved in the induction phase.
This phase involves further chemotherapy to eliminate any remaining cancer cells.
The treatment must start within 60 days of the last induction cycle.
3maintenance phase
The maintenance phase involves the administration of quizartinib or a placebo.
Quizartinib is taken orally in the form of film-coated tablets.
This phase aims to maintain remission and is conducted for up to 36 cycles.
Eligibility for this phase requires less than 5% blasts in the bone marrow and specific blood count levels.
Who Can Join the Study?
Must be able to understand, sign, and date an approved Informed Consent Form before any trial-specific procedures or tests.
Male participants must not freeze or donate sperm from the start of the trial until at least 4 months after the last dose of the study drug or 6 months after the last dose of chemotherapy, whichever is later.
Must be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and adhere to trial procedures and restrictions.
For the Consolidation Phase: Must have achieved CR (complete remission) or CRi (complete remission with incomplete blood count recovery) at the end of the Induction Phase.
For the Consolidation Phase: Must be able to start within 60 days of the last Induction cycle.
For the Maintenance Phase: Must have less than 5% of blasts in the most recent bone marrow test, done within 28 days before starting maintenance therapy.
For the Maintenance Phase: Must have an absolute neutrophil count (ANC) greater than 500/mm3 and a platelet count greater than 50,000/mm3 without needing a platelet transfusion within 24 hours before starting maintenance therapy.
For the Maintenance Phase: Must be able to start within 60 days of the last Consolidation cycle or within 180 days after a stem cell transplant, if stable after the transplant.
For participants who had a stem cell transplant: Must not have active acute or severe chronic graft-versus-host disease (GVHD).
For participants who had a stem cell transplant: Must not have started treatment for active GVHD within 21 days (preventive treatment is allowed).
For participants who had a stem cell transplant: All severe non-blood-related side effects must have improved to a mild level, except for hair loss.
Must be between 18 and 70 years old at the time of screening.
Must have newly diagnosed acute myeloid leukemia (AML) as defined by the World Health Organization in 2016.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, which measures the ability to perform daily activities.
Must be a candidate for standard “7+3” induction chemotherapy, as assessed by the investigator.
Must have required baseline laboratory data within 7 days before starting the trial drug.
If a woman of childbearing potential, must have a negative pregnancy test at the start of the trial and agree to use highly effective birth control during the trial and for 7 months after the last dose of the study drug.
Female participants must not donate or retrieve eggs for personal use from the start of the trial until at least 7 months after the last dose of the study drug.
If male, must be surgically sterile or agree to use highly effective birth control during the trial and for 4 months after the last dose of the study drug or 6 months after the last dose of chemotherapy, whichever is later.
Who Cannot Join the Study?
Patients who have been diagnosed with a type of blood cancer called acute myeloid leukemia (AML) that is not newly diagnosed.
Patients who have a specific genetic mutation known as FLT3-ITD in their leukemia cells.
Patients who are not within the specified age range for the study.
Patients who are not able to receive standard chemotherapy treatments.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of other types of cancer, unless they have been in remission for a certain period.
Patients who have allergies or reactions to the study medications.
Patients who are unable to follow the study procedures or attend the required visits.
Quizartinib is a medication being studied for its potential to help treat adults with a specific type of blood cancer called Acute Myeloid Leukemia (AML). In this trial, it is given to patients along with standard chemotherapy treatments. The goal is to see if adding quizartinib can improve the overall survival of patients who have been newly diagnosed with a form of AML that does not have a certain genetic mutation known as FLT3-ITD. Quizartinib is used during the initial treatment phase, known as induction, and the follow-up phase, known as consolidation. It is also given as a maintenance therapy to help keep the cancer from coming back.
Acute Myeloid Leukemia – Acute myeloid leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of abnormal white blood cells that interfere with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. AML is characterized by the presence of immature cells called myeloblasts in the blood and bone marrow. The disease can affect people of all ages but is more common in adults. It requires prompt medical attention due to its fast progression.
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