Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
This research study is investigating a new treatment approach for older adults diagnosed with a type of blood cancer known as diffuse large B-cell lymphoma (DLBCL). The study compares the standard treatment, called R-miniCHOP, with a combination of R-miniCHOP plus an additional drug called acalabrutinib. The main goal is to find out if adding acalabrutinib can improve how long patients live without their cancer getting worse. Participants will be randomly assigned to receive either the standard R-miniCHOP treatment alone or the R-miniCHOP treatment with acalabrutinib. This is a Phase 3 trial, meaning it's a larger study designed to confirm the effectiveness and safety of the new treatment.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research project to test new treatments. The focus is on older adults who have been diagnosed with diffuse large B-cell lymphoma (DLBCL). This is a type of cancer that affects specific white blood cells in your body.
The usual treatment for some people with DLBCL is a combination of medicines known as R-miniCHOP. In this study, researchers want to see if adding another drug, called acalabrutinib, to this standard R-miniCHOP treatment can make it even better. Acalabrutinib works by targeting specific signals within the cancer cells, aiming to stop them from growing and spreading. The main question this study hopes to answer is whether people who receive R-miniCHOP plus acalabrutinib will live longer without their cancer progressing, compared to those who only receive R-miniCHOP.
Participants in this study will be split into two groups by chance (like flipping a coin). One group will receive the standard R-miniCHOP treatment, and the other group will receive R-miniCHOP combined with acalabrutinib. This allows the researchers to fairly compare how each treatment works. By doing this research, doctors hope to find more effective ways to help older adults with DLBCL.
Key takeaways
- This study evaluates a new drug (acalabrutinib) combined with standard treatment for DLBCL.
- It's for older adults (61+) who are newly diagnosed with DLBCL.
- The main goal is to see if the new combination can help people live longer without their cancer progressing.
- You would be randomly assigned to one of two treatment groups.
- Participation involves regular clinic visits for treatment and monitoring.
Who may be eligible?
For you to be considered for this study, you would first need to understand what the study involves and agree to take part by signing an informed consent form. You'd also need to be able to swallow capsules and tablets without difficulty.
This study is for men and women who are generally aged 61 years or older. If you are over 80, you might be eligible. If you are between 61 and 80, the doctors will assess if the full standard treatment (R-CHOP) might be too strong for you based on certain health and daily activity measures. Essentially, they are looking for older adults who might benefit from a gentler approach to treatment.
Finally, you must have been diagnosed with a specific type of blood cancer called CD20+ diffuse large B-cell lymphoma, and it must be newly diagnosed (you haven't started treatment for it yet). There are also specific rules about contraception for both men and women to ensure safety during the study.
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 able to understand and sign consent forms?
- Are you 61 years of age or older?
- Have you been diagnosed with CD20+ diffuse large B-cell lymphoma (DLBCL) that hasn't been treated yet?
- Can you swallow capsules and tablets without difficulty?
- Are you comfortable with specific contraception requirements if sexually active?
What does participation involve?
If you decide to take part in this study, you will be asked to sign an informed consent form, explaining everything about the study in detail. You will be assigned by chance (randomly) to one of two treatment groups: either standard R-miniCHOP treatment alone or R-miniCHOP with acalabrutinib. This means neither you nor your doctor will get to choose which group you are in.
You will receive your assigned medication on a schedule determined by the study. This will involve regular visits to the clinic for treatments, check-ups, and to monitor how you're responding and feeling. These visits will include various tests such as blood tests, scans, and physical exams.
The duration of your treatment and follow-up will depend on your individual response and the study's protocol, but it will involve ongoing assessments over time to track your health and the cancer's status. The study carefully monitors participants throughout the treatment period and often for a period afterward.
Potential risks and benefits
Locations (17)
- Saarland University Medical CenterVerified postcodeHomburg, Germany· Recruiting
- MVZ am Klinikum AschaffenburgVerified postcodeAschaffenburg, Germany· Not yet recruiting
- Helios Klinikum Emil von BehringVerified postcodeBerlin, Germany· Recruiting
- Onkologische Schwerpunktpraxis KurfürstendammVerified postcodeBerlin, Germany· Not yet recruiting
- Gemeinschaftspraxis Mohm/Prange-KrexVerified postcodeDresden, Germany· Not yet recruiting
- Universitätsklinikum Gießen und Marburg, Standort GießenVerified postcodeGiessen, Germany· Recruiting
- Universitätsmedizin GreifswaldVerified postcodeGreifswald, Germany· Recruiting
- Universitätsmedizin Halle (Saale)Verified postcodeHalle, Germany· Recruiting
- Städtisches Klinikum KarlsruheVerified postcodeKarlsruhe, Germany· Recruiting
- Johannes Wesling KlinikumVerified postcodeMinden, Germany· Not yet recruiting
- Rheinland Klinikum-Lukaskrankenhaus NeussVerified postcodeNeuss, Germany· Not yet recruiting
- Brüderkrankenhaus St. JosefVerified postcodePaderborn, Germany· Not yet recruiting
Common questions
What is diffuse large B-cell lymphoma (DLBCL)?
DLBCL is a type of cancer that starts in certain white blood cells called B-cells. These cells usually help fight infection, but in DLBCL, they grow out of control.
What is R-miniCHOP?
R-miniCHOP is a combination of different chemotherapy drugs and a specific antibody drug often used to treat lymphoma. 'Mini' often means a slightly adjusted or lower dose suitable for older or more fragile patients.
What is acalabrutinib?
Acalabrutinib is a newer drug designed to block specific signals inside cancer cells, which can help stop them from growing and spreading. It is designed to be a more targeted treatment.
Why are older adults specifically being studied?
Older adults sometimes can't tolerate the full standard doses of chemotherapy due to other health conditions. This study explores a potentially gentler, yet effective, treatment approach for this specific group.
What does 'progression-free survival' mean?
Progression-free survival means the length of time that a patient lives with the disease without it getting worse or progressing. It's a key measure of how effective a treatment is.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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