Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

This research study is for adults with a type of blood cancer called Acute Myeloid Leukaemia (AML). It's for people who are newly diagnosed and can't have the usual strong chemotherapy treatments. The study aims to find out if adding a drug called Venetoclax to a low-dose chemotherapy drug called Cytarabine works better than Cytarabine alone. Researchers will compare how long people live (overall survival) with each treatment. They will also look at how many people go into remission, and how the treatments affect tiredness and overall quality of life. This is a "Phase III" study, meaning it's a final stage of testing before a new treatment could become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

01 Jul 2024

Acute Myeloid Leukemia

What is this study about?

This study is about finding better ways to treat Acute Myeloid Leukaemia (AML) for people who are newly diagnosed but aren't well enough for the very strong chemotherapy treatments often used. AML is a fast-growing cancer of the blood and bone marrow, and it's important to find effective, gentler options for these patients.

The study is comparing two treatment approaches: one group will receive a drug called Venetoclax along with a low dose of chemotherapy called Cytarabine. The other group will receive Cytarabine and a placebo (a dummy drug that looks like Venetoclax but has no active ingredients). This "double-blind" approach means neither the patients nor their doctors will know who is getting Venetoclax and who is getting the placebo, which helps make sure the results are fair and unbiased.

The main goal of the study is to see if the combination of Venetoclax and Cytarabine helps people live longer compared to Cytarabine alone. The researchers will also be looking at other important things, like how many people go into remission (meaning the cancer has largely gone away), how quickly this happens, and how the treatments affect patients' energy levels and general quality of life. This information helps doctors understand not just how well a treatment works, but also how it impacts daily life.

Key takeaways

This study is for adults with newly diagnosed AML who can't have strong chemotherapy.
It compares Venetoclax plus low-dose Cytarabine to low-dose Cytarabine alone.
The main goal is to see if the combination helps people live longer.
It also looks at remission rates, tiredness, and quality of life.
This is a Phase III study, the final stage before a treatment could be widely used.

Who may be eligible?

This study is looking for adults aged 18 and over who have been newly diagnosed with Acute Myeloid Leukaemia (AML).

A key part of who can join is that you must not be a suitable candidate for intensive (strong) chemotherapy. This often applies to people who might have other health conditions or whose doctors feel that strong chemotherapy would be too hard on their body.

Both men and women can take part in this study. There might be some other health checks to make sure the treatment is safe for you, but generally, it's for adults with newly diagnosed AML who need a gentler treatment 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 18 years old or older?
Have you recently been diagnosed with Acute Myeloid Leukaemia (AML)?
Has your doctor said that strong chemotherapy is not suitable for you?
Are you willing to participate in a study where you might receive a placebo?
Are you comfortable with regular hospital visits and health checks?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the combination of Venetoclax and low-dose Cytarabine, or low-dose Cytarabine with a placebo. The Cytarabine would be given as an injection or infusion. You would have regular visits with the study team for blood tests, health checks, and to answer questions about how you are feeling, including about your energy levels and general well-being.

The study would involve regular assessments to see how your leukaemia is responding to the treatment. There would also be follow-up appointments to monitor your health over time. The total duration of your involvement in the study would depend on how you respond to the treatment, but these types of studies typically involve ongoing treatment and follow-up for a significant period.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close monitoring by medical experts. However, there are also potential risks, including side effects from the investigational drugs and the possibility that the new treatment may not work better than the existing one, or may not work for you. Any side effects will be carefully monitored. You should also know that you are free to withdraw from the study at any time, for any reason, without it affecting your future 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
France

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that starts in the blood-forming cells of the bone marrow. It causes the bone marrow to make abnormal white blood cells that don't work properly.

What does 'ineligible for intensive chemotherapy' mean?

This means that for various reasons, such as age or other health conditions, a patient's doctors believe that strong, standard chemotherapy would be too risky or harmful for them.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers fairly compare how well a new treatment works.

What does a 'Phase III' study mean?

Phase III studies are the final stage of testing for a new drug. They involve a large number of patients and compare the new treatment to the best available standard treatment to confirm its effectiveness and safety.

Will I know if I'm getting Venetoclax or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until the study concludes, to ensure fair results.