Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase-I/II trial for relapsed or refractory AML patients combining cytarabine and mitoxantrone with venetoclax (TUD-RELAX1-070)

This research study is looking for adult patients with a blood cancer called Acute Myeloid Leukaemia (AML). Specifically, it's for those whose cancer has returned after initial intensive chemotherapy, including a stem cell transplant, or for those whose cancer didn't respond to the first round of treatment. The study is testing a new combination of medicines: two standard chemotherapy drugs called mitoxantrone and cytarabine, along with a newer drug called venetoclax. The main aim is to find the safest and most effective dose of this combination (Phase I) and then to see how many patients achieve remission (Phase II). This is a crucial step to find better ways to treat AML when standard approaches haven't worked or when the cancer has come back.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Technische Universitaet Dresden

Enrolment target

Start

18 Oct 2024

What is this study about?

This study is called TUD-RELAX1-070 and it's looking into new ways to treat a type of blood cancer called Acute Myeloid Leukaemia, or AML. This cancer affects the blood and bone marrow. The study is specifically for adult patients whose AML has either come back after they've had intensive treatment, including a stem cell transplant, or for those whose initial treatment didn't work. The doctors are trying to find a better way to help these patients.

The study combines a newer drug called venetoclax with two well-known chemotherapy drugs, mitoxantrone and cytarabine. Chemotherapy drugs work by killing fast-growing cells, including cancer cells. Venetoclax works in a different way, targeting specific proteins in cancer cells to help them die off. By combining these treatments, researchers hope to get a more powerful effect against the AML cells.

This study has two main parts. The first part (Phase I) is about finding the right dose of these medicines that is both safe and effective for patients. They'll start with small doses and slowly increase them while carefully watching for side effects. Once the best dose is found, the second part (Phase II) will begin. In this part, more patients will receive this dose, and doctors will closely monitor how many patients go into remission, meaning the cancer is no longer detectable or has significantly reduced.

Key takeaways

This study is for adults with AML that has returned or not responded to standard treatments.
It combines a new drug (venetoclax) with traditional chemotherapy.
The first part finds the safest drug dose, and the second part checks how well it works.
It's a way to explore new options when other treatments haven't been successful.
You'll have regular medical checks and support throughout the study.
Your safety and well-being are a top priority for the research team.

Who may be eligible?

This study is for adult patients who have Acute Myeloid Leukaemia (AML). You must be considered well enough to undergo intensive treatment, even if your cancer is tough to treat.

The study is specifically looking for people whose AML has come back after they've already had strong chemotherapy, which might have included a stem cell transplant. It's also suitable for those whose AML didn't respond at all to their very first course of standard chemotherapy.

To be considered, you need to be at least 18 years old. Both men and women can take part. The medical team will check other health details to make sure this particular treatment plan is safe 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.

I am 18 years old or older.
I have Acute Myeloid Leukaemia (AML).
My AML has either come back after initial intensive chemotherapy (possibly including a stem cell transplant), OR my AML did not respond to my first chemotherapy treatment.
My doctor believes I am well enough to receive further intensive treatment.

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be given a combination of drugs: venetoclax, mitoxantrone, and cytarabine. The frequency and duration of these treatments will depend on which part of the study you are in and how you respond. You'll have regular hospital visits for check-ups, blood tests, and other assessments to see how you're reacting to the treatment and to monitor any side effects. This might include procedures like bone marrow biopsies.

The study involves several cycles of treatment. The first part aims to find the safest dose, meaning you might be in one of the groups receiving different doses of the drugs. The second part will use the dose found to be best. The total time you'll be on the study can vary, depending on your response to treatment and the study's follow-up schedule, but it will involve ongoing check-ups for a period after treatment ends to track your long-term health. All specific details about your personalised treatment plan, including length of treatment, number of hospital visits, and what tests you will have, will be talked through with you by the study doctor and team.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of accessing new and promising treatments that aren't yet widely available, which could be helpful if standard treatments haven't worked for you. However, there are potential risks, as all medicines can have side effects, and some may be serious or unexpected. The research team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia, which is a type of cancer that affects the blood and bone marrow.

What does 'relapsed' or 'refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer didn't respond to the initial treatment given.

What are the medicines used in this study?

The study uses two standard chemotherapy drugs, mitoxantrone and cytarabine, along with a newer drug called venetoclax.

What is the goal of this study?

The study aims to find the safest and most effective dose of this drug combination and then see if it helps patients achieve remission from their AML.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.