A phase I-II, multicentre, open label clinical trial to assess the safety and tolerability of the combination of low-dose cytarabine or azacitidine, plus Venetoclax and Quizartinib in newly diagnosed acute myeloid leukemia patients aged equal or more than 60 years old ineligible for standard induction chemotherapy
This study is for people aged 60 and over who have recently been diagnosed with a type of blood cancer called acute myeloid leukaemia (AML) but are not well enough for the usual strong chemotherapy. The researchers are testing a combination of three new medicines: Quizartinib, Venetoclax (Venclyxto), and either low-dose cytarabine or azacitidine. It's a two-part study. First, they need to find the safest and most effective dose of these medicines when given together. Then, they will see how well this combination works at putting the cancer into remission (where there are no signs of the cancer). The overall aim is to find better and safer ways to treat AML in older patients.
At a glance
What is this study about?
This clinical trial is designed for older adults, specifically those aged 60 and above, who have recently been diagnosed with acute myeloid leukaemia (AML). AML is a cancer of the blood and bone marrow. Sometimes, older patients or those with other health issues can't have the standard strong chemotherapy treatments because they might be too difficult for their bodies to handle. This study is looking at an alternative approach for these patients.
The researchers are combining three different medicines that work in different ways to fight cancer: Quizartinib, Venetoclax (also known as Venclyxto), and either a medicine called low-dose cytarabine or another called azacitidine. The first part of the study is called Phase I, where the main goal is to carefully find the best and safest dose of these three medicines when given together. This is really important to make sure the treatment is as effective as possible with the fewest side effects.
Once the safest dose is found, the study moves into Phase II. In this part, more patients will receive the combination therapy at the dose identified in Phase I. The main aim here is to see how many patients achieve remission, meaning the cancer is no longer detectable or significantly reduced. The researchers will also be keeping a close eye on side effects, how long patients live, and their quality of life. This study aims to offer a new, gentler, but effective treatment option for older AML patients who currently have limited choices.
Key takeaways
- This study explores a new drug combination for older AML patients.
- It's for people aged 60+ who can't have standard chemotherapy.
- The treatment involves three specific medications given together.
- The study aims to find a safe dose and see how well it works.
- Patient safety and quality of life are closely monitored.
Who may be eligible?
This study is looking for patients who have recently been diagnosed with acute myeloid leukaemia (AML).
To join, you must be 60 years old or older. You also need to be a patient who your doctor has decided is not suitable for the standard, intensive chemotherapy treatments usually given for AML.
There might be other health conditions or blood test results that would mean you can't join, as the researchers need to make sure it's safe for you to take part. All patients, regardless of gender, can be considered for this study.
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 60 years old or older?
- Have you recently been diagnosed with acute myeloid leukaemia (AML)?
- Has your doctor said that you are not suitable for standard, intensive chemotherapy?
- Are you generally willing to attend regular hospital visits for monitoring?
What does participation involve?
If you decide to take part, you will be given the combination of study medications: Quizartinib, Venetoclax, and either low-dose cytarabine or azacitidine. You'll have regular hospital visits, especially at the beginning of the treatment, for check-ups, blood tests, and to make sure the medicines are working well and you're not having serious side effects. These visits will help the doctors adjust your treatment if needed and monitor your health closely. The exact number of visits and the duration of the treatment will depend on how you respond to the medicines, but typically these types of trials involve close monitoring for several months or longer. You will also have assessments for your quality of life, which involves filling in questionnaires.
Potential risks and benefits
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Common questions
What is acute myeloid leukaemia (AML)?
AML is a fast-growing cancer of the blood and bone marrow, where too many abnormal white blood cells are made.
Why is this study only for people aged 60 and over?
Older patients sometimes can't tolerate the strong standard chemotherapy. This study aims to find gentler but effective options for this age group.
What does 'ineligible for standard induction chemotherapy' mean?
It means your doctor thinks the usual, very strong initial chemotherapy treatment would be too risky or harmful for your health, perhaps due to your age or other health conditions.
What is a 'phase I-II' study?
Phase I is about finding the safest dose of the medicines. Phase II then checks how well that dose works to treat the cancer.
Will I know which medicines I'll get?
Yes, this is an 'open label' study, meaning both you and your doctors will know exactly which and how much medicine you are receiving.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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