A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
This is a very early, small study (Phase 1) trying out a new combination of medicines for people with specific kinds of lymphoma, like Diffuse Large B-cell Lymphoma (DLBCL), Grade 3B follicular lymphoma, High-grade B-cell lymphoma, and Epstein-Barr virus-positive DLBCL. The main goal is to see if this new treatment combination is safe for people and what side effects it might cause. Researchers will also be checking how the body handles these drugs and if they show any signs of helping to treat the lymphoma. This kind of study helps us understand if new treatments are worth further investigation in larger groups of people.
At a glance
What is this study about?
This research study is about trying out a new way to treat certain aggressive types of blood cancer called lymphomas. Specifically, it's looking at Diffuse Large B-cell Lymphoma (DLBCL), which is the most common fast-growing lymphoma, along with a few other related types. Doctors are trying a combination of several existing cancer medicines, including cyclophosphamide, doxorubicin, and prednisone (often called CHP), along with rituximab, and two newer drugs called venetoclax and polatuzumab vedotin. Both venetoclax and polatuzumab vedotin are designed to target cancer cells in specific ways.
Because this is a 'Phase 1' study, it's one of the very first times this exact combination of drugs will be given to people. The main focus at this stage is to make sure the treatment is safe and to find the right dose. Scientists will also observe how the body processes these medicines and look for any early signs that the treatment might be effective against the lymphoma.
The information learned from this study is really important because it helps scientists decide if this new combination should be tested in more people in larger studies. The hope is to find better and safer ways to treat these challenging types of lymphoma in the future. It's a foundational step in developing new treatments.
Key takeaways
- This is an early-stage study (Phase 1) for specific lymphomas.
- It tests a new combination of anti-cancer drugs.
- The main goal is to check for safety and find the right dose.
- Participants must have untreated Diffuse Large B-cell Lymphoma (DLBCL) or similar types.
- You'll receive active treatment, no placebo.
- Close monitoring for side effects and effectiveness is part of the study.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. Both men and women can take part. Researchers are looking for people who have not yet received treatment for specific types of lymphoma, including Diffuse Large B-cell Lymphoma (DLBCL), a type called Grade 3B follicular lymphoma, High-grade B-cell lymphoma, and Epstein-Barr virus-positive DLBCL.
There will be other health checks and tests to make sure that the study treatment is suitable and safe for you. For example, doctors will confirm your lymphoma has a certain marker called BCL-2. They will also need to check your general health, organ function, and if you have any other serious medical conditions that might make taking part risky.
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 been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL), or a very specific similar type?
- Has your lymphoma not been treated yet?
- Does your lymphoma have a specific marker called BCL-2?
- Are you able to attend regular hospital visits for treatment and check-ups?
What does participation involve?
If you decide to join this study, you would receive the new combination treatment according to a specific schedule set by the research doctors. This will involve regular visits to the hospital or clinic for treatments, blood tests, physical exams, and other medical assessments like scans. The number and frequency of these visits will depend on the study plan. You'll be closely monitored for any side effects and to see how your body is responding to the medication. The total duration of your participation in the study, including treatment and follow-up, would be fully explained to you by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What does 'Phase 1' mean?
Phase 1 means this is one of the very first times this treatment combination is being tested in people. The main goal is to find a safe dose and look for any side effects.
What is DLBCL?
DLBCL stands for Diffuse Large B-cell Lymphoma. It's a fast-growing type of blood cancer that affects white blood cells called lymphocytes.
Will I get a new drug or a placebo?
In this study, everyone will receive the new combination of drugs. There is no placebo (dummy treatment) involved.
How long will I be in the study?
The exact length of time will be explained by the study team, as it varies depending on the treatment plan and follow-up requirements.
Who can join this study?
People aged 18 or over with certain types of untreated lymphoma, including DLBCL with a specific marker, can be considered for the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.