Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
This research study is for adults who have recently been diagnosed with a type of blood cancer called Acute Myeloid Leukaemia (AML). Specifically, it's for those whose AML is 'FLT3-ITD negative', meaning a particular genetic change isn't present. We're testing a new medication called quizartinib alongside standard chemotherapy. Some participants will receive quizartinib, while others will receive a dummy pill (placebo), both with chemotherapy. The main goal is to see if adding quizartinib helps people live longer and if it's safe to use. This is a Phase 3 trial, meaning it’s a big study to confirm the drug's effectiveness and safety.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment approach for adults who have recently been diagnosed with a serious blood cancer called Acute Myeloid Leukaemia (AML). AML affects the blood and bone marrow, leading to too many abnormal white blood cells. This particular study focuses on a specific group of AML patients whose cancer cells do not have a certain genetic change, known as 'FLT3-ITD negative'.
The study aims to find out if adding a drug called quizartinib to the standard chemotherapy treatment can lead to better outcomes for these patients. Standard chemotherapy is a common treatment for AML that uses powerful medicines to kill cancer cells. Quizartinib is a newer drug that works differently to target cancer cells. For comparison, some patients will receive a placebo (an inactive dummy pill) along with their chemotherapy, so researchers can accurately assess the effects of quizartinib.
The main question this study hopes to answer is whether the combination of quizartinib and chemotherapy helps patients live longer compared to chemotherapy alone. It will also look at the safety of quizartinib and how it affects patients' overall health. The results from this study could help doctors understand if quizartinib could become a new standard treatment option for AML patients who are FLT3-ITD negative.
Key takeaways
- This study is for adults with newly diagnosed 'FLT3-ITD negative' AML.
- It tests a new drug, quizartinib, with standard chemotherapy.
- Participation involves either quizartinib or a placebo plus chemotherapy.
- The main goal is to see if quizartinib improves survival and is safe.
- It's a large-scale (Phase 3) study to confirm the drug's benefits.
- You can withdraw at any time without affecting your care.
Who may be eligible?
To join this study, you must be an adult between 18 and 70 years old who has recently been diagnosed with Acute Myeloid Leukaemia (AML). Importantly, tests will be done to confirm that your specific type of AML does not have a genetic change called 'FLT3-ITD'. You also need to be generally well enough to receive standard chemotherapy, as assessed by the study doctors.
There are certain situations that would mean you couldn't take part. For example, if you have a different specific type of leukaemia, such as Acute Promyelocytic Leukaemia (APL), or if your AML developed because of previous cancer treatment. Also, if your AML started from another blood disorder like myelodysplastic syndrome (MDS) or if your AML has the 'FLT3-ITD' genetic change, you wouldn't be able to join this particular study.
This study is for people who haven't received prior treatment for AML, except for certain emergency measures like blood cell removal or specific short-term medications to manage symptoms. The study team will review all your medical information carefully to see if this study is suitable 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 70 years old?
- Have you recently been diagnosed with Acute Myeloid Leukaemia (AML)?
- Have tests shown your AML is 'FLT3-ITD negative' (this is important!)?
- Are you well enough to receive standard chemotherapy, as advised by your doctor?
- Have you not received prior treatment for your AML (other than specific emergency measures)?
- Do you not have other specific types of leukaemia or blood disorders like APL or MDS?
What does participation involve?
If you decide to take part in this study, you will first undergo a screening process to confirm you meet all the criteria. This will involve various tests, including blood tests to check your AML type.
Once enrolled, you will receive standard chemotherapy treatment, as well as either quizartinib or a placebo (dummy pill). The quizartinib or placebo will be taken during your chemotherapy cycles and then continued for up to 36 cycles (about three years) as a maintenance therapy after chemotherapy is completed. You will have regular visits to the hospital for treatment, check-ups, and tests to monitor your health and how you are responding to the treatment.
The study team will explain the full schedule of hospital visits, assessments, and medication. The total duration of your participation could be several years, encompassing both active treatment and long-term follow-up to track your health outcomes.
Potential risks and benefits
Locations (288)
- City of Hope PhoenixVerified postcodeGoodyear, United States· Recruiting
- Mayo Clinic - PhoenixVerified postcodePhoenix, United States· Recruiting
- University of Arizona Cancer CenterVerified postcodeTucson, United States· Recruiting
- David Geffen School of MedicineVerified postcodeLos Angeles, United States· Recruiting
- University of California Davis Health SystemVerified postcodeSacramento, United States· Recruiting
- Ucsf - School of MedicineVerified postcodeSan Francisco, United States· Recruiting
- Stanford University School of Medicine- ParentVerified postcodeStanford, United States· Recruiting
- Colorado Blood Cancer InstituteVerified postcodeDenver, United States· Recruiting
- Yale UniversityVerified postcodeNew Haven, United States· Recruiting
- Sibley Memorial HospitalVerified postcodeWashington D.C., United States· Recruiting
- Mayo Clinic HospitalVerified postcodeJacksonville, United States· Recruiting
- Florida Hospital Cancer Institute - KissimmeeVerified postcodeKissimmee, United States· Recruiting
Common questions
What is high-grade AML?
Acute Myeloid Leukaemia (AML) is a fast-growing cancer of the blood and bone marrow. It's often described as 'high-grade' because it develops quickly and requires urgent treatment.
What does 'FLT3-ITD negative' mean for me?
It means your AML cells have been specifically tested and do not show a particular genetic change called FLT3-ITD. This detail helps doctors classify your AML and decide which treatments might be most effective for you.
Will I definitely get the new drug, quizartinib?
This study is 'randomised', meaning you have an equal chance of receiving quizartinib or a placebo (dummy pill) alongside your standard chemotherapy. The researchers decide this randomly, like flipping a coin, so neither you nor your doctor can choose.
What is a placebo?
A placebo is an inactive pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the effects of the active drug against no drug, ensuring any benefits or side effects are truly from the medication being tested.
How long will I be in this study?
Your participation in the study will involve receiving treatment during chemotherapy and then continuing with quizartinib or placebo for up to 36 cycles (around three years) as a maintenance treatment. You will also have follow-up appointments after this period.
How to find out more
Daiichi Sankyo Contact for Clinical Trial Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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