Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
This research study is for adults with a type of blood cancer called Acute Myeloid Leukaemia (AML) who cannot have very strong chemotherapy. The study is investigating a new medication called cusatuzumab, which will be given alongside other common AML treatments like azacitidine and venetoclax. The main goal is to understand how safe this combination of drugs is and how well people tolerate them. Because it's an early-stage study (Phase 1), researchers are carefully watching for any side effects and determining the best ways to give these medicines together. It’s an important step in finding better ways to treat AML.
At a glance
What is this study about?
If you or someone you know has been diagnosed with Acute Myeloid Leukaemia (AML), you might be wondering about new treatment options. This study is exploring a new drug called cusatuzumab. AML is a fast-growing cancer of the blood and bone marrow, and for some people, intensive chemotherapy isn't suitable, perhaps because of other health conditions or their age. This trial is specifically designed for these individuals, offering an alternative approach.
The main purpose of this early-stage (Phase 1) study is to see how safe cusatuzumab is when combined with other established AML treatments, such as azacitidine and venetoclax. Researchers want to understand if these drugs can be given together without too many side effects, and how well people can tolerate the combination. It's a crucial step because before new treatments can be widely used, doctors need to be sure they are safe.
The insights gained from this study will help doctors learn more about cusatuzumab and its potential role in treating AML. By participating, individuals contribute valuable information that could lead to new and more effective treatment strategies for others with AML in the future. It’s about carefully testing new ideas to improve care.
Key takeaways
- Targets newly diagnosed AML in adults not suitable for intensive chemotherapy.
- Investigates a new drug, cusatuzumab, combined with existing AML treatments.
- Main goal is to assess safety and how well people tolerate the drug combination.
- It's an early-stage study (Phase 1) to gather important safety information.
- Participants will receive close medical monitoring throughout the study.
Who may be eligible?
This study is looking for adults aged 18 or older who have been recently diagnosed with Acute Myeloid Leukaemia (AML). This is specifically for people whose AML cannot be treated with strong, intensive chemotherapy, perhaps due to other health reasons or their overall fitness. It doesn't matter if your AML started on its own or developed after other conditions.
There are a few conditions that would mean you couldn't join. For example, if your AML has spread to your brain or spinal cord, or if you're able to have a stem cell transplant right now, this study wouldn't be suitable. Also, if you've recently had certain vaccines or have HIV, you wouldn't be able to take part. Researchers also need to make sure you don't have known allergies to any of the study medications or their ingredients.
Sometimes, to manage your condition before the study starts, you might have had certain initial treatments like hydroxyurea or very low-dose chemotherapy for a short time. This is generally OK, as long as these treatments were stopped at least 24 hours before you start the study drugs. The most important thing is that the research team will carefully check all your medical information to see if this study is the right fit 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.
- Are you 18 years old or older?
- Have you recently been diagnosed with Acute Myeloid Leukaemia (AML)?
- Have your doctors said that strong, intensive chemotherapy is not suitable for you?
- Do you NOT have AML that has spread to your brain or spinal cord?
- Are you NOT allergic to cusatuzumab, azacitidine, venetoclax, or similar medications?
What does participation involve?
If you decide to take part in this study, you will receive the new drug cusatuzumab along with either azacitidine or venetoclax, depending on what the study doctors decide is best for your specific situation. The study team will regularly monitor your health, perform blood tests, and ask you about how you are feeling to check for any side effects and to see how your body is responding to the treatment. The exact number of hospital visits, assessments, and the full duration of your participation will be carefully explained by the study team. You will be given detailed information about the study schedule before you make any decisions.
Potential risks and benefits
Locations (23)
- City of HopeVerified postcodeDuarte, United States
- Norton Cancer InstituteVerified postcodeLouisville, United States
- Barbara Ann Karmanos Cancer InstituteVerified postcodeDetroit, United States
- Roswell Park Cancer InstituteVerified postcodeBuffalo, United States
- Weill Cornell MedicineVerified postcodeNew York, United States
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States
- University of RochesterVerified postcodeRochester, United States
- University of Pittsburgh School of MedicineVerified postcodePittsburgh, United States
- The University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States
- University of VermontVerified postcodeBurlington, United States
- Wisconsin Medical CenterVerified postcodeMilwaukee, United States
- Tom Baker Cancer CentreVerified postcodeCalgary, Canada
Common questions
What is Acute Myeloid Leukaemia (AML)?
AML is a type of cancer that affects the blood and bone marrow, causing the body to make too many abnormal white blood cells.
What is cusatuzumab?
Cusatuzumab is a new investigational drug being tested to see if it can help treat AML.
Why is this study only for people who can't have strong chemotherapy?
This study aims to find new treatment options for patients who aren't suitable for intensive chemotherapy due to age or other health conditions.
Will I know which treatment I'm getting?
Yes, in this type of study, you will know you are receiving cusatuzumab along with standard AML treatments like azacitidine or venetoclax.
What phase is this study in?
This is a Phase 1 study, meaning it's an early stage where doctors are primarily checking the safety of the new drug combination and finding the right dosage.
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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