A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
This study is for adults in Canada who have a blood and bone marrow cancer called Acute Myeloid Leukaemia (AML). It focuses on patients who aren't able to have a common, strong chemotherapy treatment. The main goal is to understand how effective venetoclax, a medication already approved for AML, is in this group of patients. Venetoclax will be given as tablets, taken daily, just as a doctor would normally prescribe it. About 200 people across Canada will take part. The study will last around three years, checking in on patients during their regular doctor visits. It aims to gather information without adding extra appointments or burdens for those involved.
At a glance
What is this study about?
Acute Myeloid Leukaemia (AML) is a type of cancer that affects your blood and bone marrow. It's the most common kind of fast-growing leukaemia in adults. This study is being set up to learn more about how well a particular medicine, called venetoclax, works for adults with AML.
Specifically, this research is for people who, for various health reasons, cannot have a very intensive type of chemotherapy, which is a common strong treatment for AML. Your doctor will have already decided that venetoclax is the right treatment for you before you're even asked to join this study.
Venetoclax is a medication that is already approved for treating AML. This study will simply observe how people respond to venetoclax when it's prescribed in the usual way by their doctor. The information gathered will help doctors and researchers understand more about the treatment's effectiveness in a real-world setting for this specific group of patients.
Key takeaways
- The study is for adults with AML who can't have strong chemotherapy.
- It observes how venetoclax works when prescribed normally.
- Venetoclax is an approved medicine for AML.
- Participation involves no extra appointments; all visits are part of routine care.
- The study lasts approximately three years.
- Around 200 people in Canada will take part.
Who may be eligible?
To join this study, you must be an adult (18 years or older) and have received a diagnosis of Acute Myeloid Leukaemia (AML).
Crucially, your doctor must have decided that strong, intensive chemotherapy is not suitable for you. This decision will be based on things like your age, general health, any other health conditions you have, and local medical guidelines. You must also be a patient for whom your doctor has already decided to treat with venetoclax, following the standard guidelines for its use.
You cannot join if you've already taken part in another experimental clinical trial within the last 30 days before starting venetoclax.
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 adult (18 years or older)?
- Have you been diagnosed with Acute Myeloid Leukaemia (AML)?
- Has your doctor said that strong, intensive chemotherapy is not suitable for you?
- Has your doctor already decided to treat your AML with venetoclax?
- Have you *not* participated in another experimental study in the last 30 days?
What does participation involve?
If you decide to take part, you will be given venetoclax tablets to take by mouth every day, exactly as your study doctor prescribes. This is how venetoclax is normally given. The study will follow your progress for about 36 months, which is around three years.
The good news is that there are no extra appointments or tests required just for this study. All your check-ups and follow-ups will happen during your regular visits to the clinic, as part of your usual care. This means the study shouldn't add any extra burden to your treatment routine.
Potential risks and benefits
Locations (20)
- Tom Baker Cancer Centre /ID# 248113Verified postcodeCalgary, Canada
- University of Alberta Hospital /ID# 251531Verified postcodeEdmonton, Canada
- BC Cancer - Surrey /ID# 257515Verified postcodeSurrey, Canada
- Vancouver General Hospital /ID# 245438Verified postcodeVancouver, Canada
- BC Cancer - Victoria /ID# 257339Verified postcodeVictoria, Canada
- CancerCare Manitoba /ID# 246414Verified postcodeWinnipeg, Canada
- The Moncton Hospital /ID# 247277Verified postcodeMoncton, Canada
- Eastern Regional Health Authority /ID# 250241Verified postcodeSt. John's, Canada
- Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 246514Verified postcodeHalifax, Canada
- Juravinski Cancer Centre /ID# 247183Verified postcodeHamilton, Canada
- Kingston Health Sciences Centre /ID# 253439Verified postcodeKingston, Canada
- London Health Sciences Center- University Hospital /ID# 248027Verified postcodeLondon, Canada
Common questions
What is Acute Myeloid Leukaemia (AML)?
AML is a type of cancer that starts in the blood-forming cells of your bone marrow.
What is venetoclax?
Venetoclax is a medicine approved to treat AML. It's taken as tablets.
Will I have extra appointments if I join?
No, all your study visits will happen during your regular doctor's appointments, so there are no extra trips to the clinic.
How long will the study last?
The study will follow participants for about 36 months, which is around three years.
Can I leave the study if I change my mind?
Yes, you can decide to stop participating at any time, and it 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.
Discussion
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