A PHASE I/II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MEBENDAZOLE IN COMBINATION WITH LOW-DOSE ARA-C IN ELDERLY PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (MAIL)
This study is for older patients with acute myeloid leukaemia (AML). This is a type of blood cancer where treatments have either not worked well or have stopped working (relapsed/refractory). The trial is testing a new treatment approach that combines two existing medicines: mebendazole (sometimes used for worm infections) and a low dose of Ara-C (a chemotherapy drug). The main goals are to find a safe dose of mebendazole and to see how many patients respond to this combination therapy. Researchers will also look at how patients feel and how long they live after treatment, as well as how the cancer cells change with the treatment.
At a glance
What is this study about?
This research study is about finding new ways to treat a type of blood cancer called acute myeloid leukaemia (AML). AML is a serious condition, and sometimes treatments don't work as well as hoped, or the cancer comes back after getting better. When this happens, it's called 'relapsed/refractory' AML. This study focuses on older patients who are in this situation.
The researchers are combining two medicines that are already known: mebendazole and a low dose of Ara-C. Mebendazole is usually used to treat worm infections, but some studies suggest it might have anti-cancer effects. Ara-C is a type of chemotherapy that targets fast-growing cells, including cancer cells. The idea behind this study is to see if combining these two drugs can be a safe and effective new treatment option.
The study has two main parts. The first part (Phase I) is about finding the right and safest dose of mebendazole to use when combined with Ara-C. Researchers will carefully watch for any side effects. Once a safe dose is found, the second part (Phase II) will look at how well this combination treatment works. They will check how many patients see their cancer improve or go into remission.
Key takeaways
- This study is for older patients whose AML has returned or hasn't responded to previous treatments.
- It's testing a new combination of mebendazole and a low dose of Ara-C.
- The study aims to find a safe dose and see how well the combination works.
- Participation involves regular clinic visits for monitoring and treatment.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is looking for older patients who have acute myeloid leukaemia (AML). This means your specific type of blood cancer has either returned after treatment or has not responded well to previous treatments.
There are many other detailed criteria that decide who can or cannot join a study, such as your general health, other medical conditions, and previous treatments you've had. These are in place to make sure the study is safe for you and that the results are clear.
If you think you might be eligible, the best step is to talk to your doctor. They can review all the criteria with you and help you understand if this study could be an option.
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 an older adult with acute myeloid leukaemia (AML)?
- Has your AML returned after previous treatment?
- Has your AML not responded to previous treatments?
- Are you generally well enough to take part in a clinical study?
- Have you discussed your other medical conditions and current medications with your doctor?
What does participation involve?
If you decide to take part in this study, you will receive the study medications (mebendazole and low-dose Ara-C) according to a specific schedule. You will have regular visits to the clinic for check-ups, blood tests, and possibly other procedures like bone marrow biopsies, to see how you are responding to the treatment and to monitor for any side effects. The exact number of visits and tests will be explained to you by the study team.
The study will involve close monitoring of your health and the effects of the treatment. The researchers will be looking at how frequently side effects occur and how severe they are. They will also assess how well the treatment is working by checking your blood counts and other markers related to your AML. The treatment phase itself will last for a certain period, and you will likely have follow-up visits even after you finish the main treatment, to track your long-term health.
The total duration of your involvement could vary, depending on how long you receive treatment and the follow-up schedule. All details would be fully explained to you before you agree to participate.
Potential risks and benefits
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Common questions
What is 'relapsed/refractory AML'?
This means your acute myeloid leukaemia (AML) has either returned after previous treatment or hasn't responded to earlier treatments.
What are mebendazole and Ara-C?
Mebendazole is a medicine usually used for worm infections, and Ara-C is a type of chemotherapy. In this study, they are being tested together against AML.
Will I know if the treatment is working?
The study team will regularly check your blood and perform other tests to see how your AML is responding and will share these updates with you.
What happens if I experience side effects?
The study team will closely monitor you for any side effects and will provide care and advice on how to manage them.
Can I stop participating in the study at any time?
Yes, you can choose to leave the study at any point, and this won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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