A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
This study is investigating a new combination treatment for adults with follicular lymphoma (FL) or marginal zone lymphoma (MZL). These are types of non-Hodgkin's lymphoma that have either come back after treatment or didn't respond to initial therapies. The study combines an experimental drug called odronextamab with lenalidomide, an existing medication. In the second part of the study, this new combination will be compared to a standard treatment that uses rituximab and lenalidomide. Researchers want to see if the new combination is safe, works better than the standard treatment, and how it affects patients' quality of life. The study aims to find the right dose for the new drug and understand any potential side effects.
At a glance
What is this study about?
This research study is about finding new and better ways to treat two specific types of non-Hodgkin's lymphoma: follicular lymphoma (FL) and marginal zone lymphoma (MZL). These are cancers that affect certain white blood cells. This study is for people whose lymphoma has either returned after previous treatments or didn't get better with their initial treatment. We call this 'relapsed' or 'refractory' lymphoma.
The study involves an experimental drug called odronextamab. This drug will be given alongside lenalidomide, which is already a commonly used medication in cancer treatment. The study has two main parts. The first part is designed to safely find the best dose of odronextamab when given with lenalidomide and to check for any early side effects. This combination hasn't been tested in humans before.
The second part of the study will then compare this new combination (odronextamab plus lenalidomide) to a standard treatment. The standard treatment for this type of lymphoma is rituximab plus lenalidomide. Researchers want to see if the new combination works better at shrinking the lymphoma and improving patients' health, while keeping side effects manageable. They will also look at how patients feel and if their daily activities are affected.
Key takeaways
- This study is testing a new combination treatment for specific types of lymphoma.
- It's for lymphoma that has returned or didn't respond to previous treatments.
- The new therapy (odronextamab + lenalidomide) is compared to standard treatment (rituximab + lenalidomide).
- It aims to find out if the new treatment is safe and more effective.
- You might receive the new treatment or the standard treatment, chosen at random.
- Participation involves regular check-ups and monitoring of your health.
Who may be eligible?
To join this study, adults must have been diagnosed with follicular lymphoma (grades 1-3a) or marginal zone lymphoma (nodal, splenic, or outside of organs). Your lymphoma needs to have either come back after at least one previous treatment, or it didn't respond to previous treatments. These treatments must have included a specific type of drug called an anti-CD20 therapy.
Doctors will need to be able to measure your lymphoma using scans like CT or MRI. You should be generally well enough to take part in a study, meaning you can mostly go about your daily activities. You'll also need to have healthy blood counts and organ function. Importantly, if you can become pregnant or get someone pregnant, you must understand the risks of lenalidomide to unborn babies and agree to use effective contraception.
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.
- Do you have follicular lymphoma (grades 1-3a) or marginal zone lymphoma?
- Has your lymphoma returned or not responded to previous treatments?
- Did your previous treatment include an anti-CD20 drug?
- Are you generally well and able to carry out most daily activities?
- Are you willing to use effective birth control if applicable, due to medication risks?
- Do you have good kidney, liver, and blood cell function?
What does participation involve?
If you decide to take part, the first part of the study will involve finding the right dose of the new drug, odronextamab, when combined with lenalidomide. In the second part, you would be randomly assigned to receive either the new combination (odronextamab plus lenalidomide) or the standard treatment (rituximab plus lenalidomide). This is like tossing a coin, so neither you nor your doctor can choose which treatment you get.
Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your lymphoma and side effects. You'll also be asked questions about how you feel and how the treatment affects your daily life. You'll need to take the study medication as instructed and follow specific precautions, especially regarding pregnancy risks if you are taking lenalidomide. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it generally involves ongoing monitoring and follow-up.
Potential risks and benefits
Locations (169)
- David Geffen School of Medicine at UCLAVerified postcodeLos Angeles, United States· Recruiting
- Boca Raton Clinical Research (BRCR) GlobalVerified postcodePlantation, United States· Recruiting
- Indiana University and Comprehensive Cancer CenterVerified postcodeIndianapolis, United States· Recruiting
- Hattiesburg ClinicVerified postcodeHattiesburg, United States· Recruiting
- Dartmouth Cancer CenterVerified postcodeLebanon, United States· Recruiting
- Stony Brook University HospitalVerified postcodeStony Brook, United States· Recruiting
- Clinical Research Alliance IncVerified postcodeWestbury, United States· Withdrawn
- Prohealth Care IncVerified postcodeWaukesha, United States· Recruiting
- Liverpool HospitalVerified postcodeLiverpool, Australia· Recruiting
- Calvary Mater NewcastleVerified postcodeWaratah, Australia· Recruiting
- Pindara Private HospitalVerified postcodeBenowa, Australia· Recruiting
- Royal Hobart HospitalVerified postcodeHobart, Australia· Recruiting
Common questions
What is follicular lymphoma and marginal zone lymphoma?
These are slow-growing types of cancer that affect certain white blood cells, called B-lymphocytes, which are part of your immune system.
What does 'relapsed/refractory' mean?
It means your cancer has either come back after previous treatment, or it didn't fully respond to your initial treatments.
What is a 'standard-of-care' treatment?
This refers to the best and most widely accepted treatment that medical experts currently recommend for a specific condition.
Will I definitely get the new drug?
In the main part of the study, you'll be randomly assigned to either the new drug combination or the standard treatment, so it's not guaranteed you'll get the new one.
How long will the study last?
The study length will vary for each person, depending on their response to treatment and the study's monitoring schedule.
How to find out more
Clinical Trials Administrator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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