A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
This study is looking into a new treatment for adults with follicular lymphoma, which is a type of non-Hodgkin lymphoma. The new treatment involves an experimental drug called odronextamab combined with chemotherapy. Researchers want to find out if this combination is safe, how well people tolerate it, and if it works better than the standard treatment, which is rituximab combined with chemotherapy. The study also aims to understand any side effects of odronextamab, how it moves through the body, and its impact on a person's daily life and well-being. It's for people with newly diagnosed follicular lymphoma, though some parts of the study might include those whose lymphoma has returned or didn't respond to previous treatments.
At a glance
What is this study about?
This research study is testing a new medicine called odronextamab for adults who have a type of cancer called follicular lymphoma. Follicular lymphoma is a form of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells called lymphocytes. The study wants to see how this new drug works when given alongside chemotherapy. Researchers will compare this new combination directly with the current standard treatment, which uses a drug called rituximab along with chemotherapy.
The study has a few main goals. First, it wants to make sure the new drug combination is safe and that people can tolerate it without too many problems. Second, it aims to find the best dose and schedule for giving odronextamab with chemotherapy. Finally, the main part of the study will compare how effective this new combination is at treating follicular lymphoma compared to the usual treatment. This will help doctors understand if odronextamab could be a better option in the future.
Beyond comparing the treatments, the study is also looking at other important questions. This includes tracking any side effects that might happen, seeing how the new drug moves through the body, and checking if the body responds to the drug in a way that might make it less effective. The study will also look at how the treatment might affect a person's quality of life and their ability to do everyday activities, which is a very important part of managing any condition.
Key takeaways
- This study is testing a new drug (odronextamab) for follicular lymphoma.
- It compares the new drug with chemotherapy to the standard treatment (rituximab with chemotherapy).
- Researchers want to understand if the new treatment is safe, well-tolerated, and effective.
- The study includes adults with newly diagnosed follicular lymphoma, and some with returning or unresponsive lymphoma.
- Participation involves regular clinic visits, tests, and closely monitored care.
- Your decision to join or leave the study will not affect your relationship with your doctor.
Who may be eligible?
To join this study, you need to be an adult (18 or older) diagnosed with follicular lymphoma. Your lymphoma must show certain features when tested, and doctors will check if it can be measured on scans like CT or MRI.
There are different parts to this study, and the exact requirements might vary slightly. Generally, you'll be considered if you have newly diagnosed follicular lymphoma. In some cases, if your lymphoma has come back after treatment or didn't respond to previous treatments, you might be able to join an earlier part of the study.
However, some conditions would mean you couldn't join. For example, if your lymphoma has spread to your brain or spinal cord, or if it has changed into a more aggressive type. Other health issues, like requiring a recent major surgery or having certain other types of cancer or blood disorders, would also prevent you from participating to ensure your safety.
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?
- Do you have a diagnosis of follicular lymphoma specifically, not other types like chronic lymphocytic leukaemia?
- Have you been told your follicular lymphoma is considered newly diagnosed, or has it returned/not responded to previous treatment (for Part 1A)?
- Are you able to manage most of your daily activities without significant help?
- Do you feel well enough in general to participate in a clinical trial?
- Have you had no major surgery recently or an organ transplant?
What does participation involve?
If you decide to take part in this study, you will receive either the new study drug (odronextamab) along with chemotherapy, or the standard treatment (rituximab) with chemotherapy. The study involves regular visits to the hospital or clinic for treatment, check-ups, and to monitor your health. These visits will include various tests, such as blood tests, scans (like CT or MRI), and physical examinations.
Some parts of the study involve finding the right dose, while other parts will randomly assign you to one of the treatment groups, like flipping a coin. You won't be able to choose which treatment you receive in these parts. You'll be closely monitored for any side effects and to see how well the treatment is working. The total duration of your participation will depend on the specific part of the study you join and how your treatment progresses, but studies like this can last for several months or even longer, with ongoing follow-up after active treatment.
Potential risks and benefits
Locations (145)
- Boca Raton Clinical Research (BRCR) GlobalVerified postcodePlantation, United States
- Investigative Clinical Research of IndianaVerified postcodeNoblesville, United States
- Cancer Center of KansasVerified postcodeWichita, United States
- University of KentuckyVerified postcodeLexington, United States
- Henry Ford Health SystemVerified postcodeDetroit, United States
- Cancer and Hematology Centers of Western MichiganVerified postcodeGrand Rapids, United States
- Center for Oncology and Blood DisordersVerified postcodeHouston, United States
- Community Cancer Trials of UtahVerified postcodeOgden, United States
- Prohealth Care IncVerified postcodeWaukesha, United States
- Liverpool HospitalVerified postcodeLiverpool, Australia
- Calvary Mater NewcastleVerified postcodeWaratah, Australia
- Pindara Private HospitalVerified postcodeBenowa, Australia
Common questions
What is follicular lymphoma?
Follicular lymphoma is a type of cancer that starts in white blood cells, which are part of your immune system. It's a slow-growing type of non-Hodgkin lymphoma.
What is 'standard-of-care' treatment?
Standard-of-care means the usual, widely accepted, and best-known treatment that doctors use for a particular illness at a given time.
Will I definitely get the new drug?
In some parts of the study, you might be randomly assigned to receive either the new drug combination or the standard treatment, like drawing lots. In other early parts, everyone might receive the new drug.
What are 'side effects'?
Side effects are unwanted or unpleasant effects that can happen when taking a medicine. The study will carefully monitor you for any side effects from the treatments.
Can I stop participating in the study if I want to?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your current or future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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