A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
This research is testing a new medicine called odronextamab alongside chemotherapy for adults with a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). The study involves people who have just been diagnosed and not yet treated, or those whose lymphoma has returned or didn't respond to previous treatments. It aims to see if odronextamab plus chemotherapy is safer and works better than the current standard treatment, which involves rituximab plus chemotherapy. Researchers will also look at any side effects, how the drug acts in the body, and its impact on your quality of life. This is a Phase 3 study, meaning it's well into testing the new treatment against existing ones.
At a glance
What is this study about?
This study is looking into a new treatment for a type of blood cancer called Diffuse Large B-cell Lymphoma (DLBCL). DLBCL is a fast-growing lymphoma, and the aim of this research is to find more effective ways to treat it.
The study involves comparing a new experimental drug, called odronextamab, when given with standard chemotherapy, against the current standard treatment, which is rituximab plus chemotherapy. Researchers want to understand if the new odronextamab combination is better at treating DLBCL and if it's safe for patients. They are particularly interested in people who haven't had treatment before, or those whose lymphoma has come back or hasn't responded to previous treatments.
Initially, the study will check different doses of odronextamab to find the safest and most effective amount to use. Once this is decided, a larger group of patients will receive either the new odronextamab combination or the standard rituximab combination. The study isn't just about how well the drugs fight the cancer; it also examines potential side effects, how the drugs behave in the body, and importantly, how they affect a patient's daily life and overall well-being. This information helps doctors understand the full picture of a new treatment.
Key takeaways
- The study tests a new drug, odronextamab, for DLBCL.
- It compares the new drug with current standard treatment, both alongside chemotherapy.
- It includes patients who haven't been treated before, or whose lymphoma has returned.
- Researchers will check how safe and effective the treatments are.
- They will also look at how treatments affect patients' quality of life.
- It's a Phase 3 study, meaning it's a key step in testing new treatments.
Who may be eligible?
This study is mainly for adults who have Diffuse Large B-cell Lymphoma (DLBCL) and haven't had treatment for it before. It might also be open to people whose DLBCL has returned or hasn't responded to previous treatments, especially if standard treatments aren't suitable for them.
To join, you would need to have clear signs of the lymphoma that can be measured. Your general health would need to be good enough to take part, meaning your body and organs are working well, and you can manage most daily activities without too much difficulty. For those who haven't been treated before, your doctors will also look at a specific score that helps predict how the lymphoma might behave.
There are also reasons why someone might not be able to join. For example, if your lymphoma is in your brain or spinal cord, or if you have another active cancer or a serious ongoing health condition. Certain infections like uncontrolled HIV, Hepatitis B or C, or active COVID-19, would also prevent participation, as would severe nerve damage. If you've recently had major surgery, an organ transplant, or certain types of radiotherapy, or if you're allergic to any of the study medications, you wouldn't be able to join. This helps ensure the safety of everyone taking part.
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 an adult aged 18 or over?
- Have you been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)?
- Have you NOT been treated for DLBCL before, or has your DLBCL come back after treatment?
- Are you generally well enough to manage most daily activities?
- Do you have a clear sign of lymphoma that can be measured by doctors?
- Are you free from certain other serious health issues or infections, like uncontrolled HIV or Hepatitis?
What does participation involve?
If you decide to join this study, you would receive either the new study drug, odronextamab, along with chemotherapy, or the standard treatment, rituximab, with chemotherapy. These drugs are usually given through a drip (intravenously). You would have regular hospital visits for treatments, blood tests, scans, and check-ups to see how you're responding and to monitor for any side effects. Researchers will collect information on your health, any side effects you experience, and how the medicine affects your quality of life through questionnaires. The total duration of your participation would depend on how your treatment progresses and could involve follow-up visits even after treatment stops.
Potential risks and benefits
Locations (155)
- David Geffen School of Medicine at UCLAVerified postcodeLos Angeles, United States· Recruiting
- University of California Irvine Medical CenterVerified postcodeOrange, United States· Recruiting
- University of California (UC) DavisVerified postcodeSacramento, United States· Recruiting
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterVerified postcodeIndianapolis, United States· Recruiting
- St Vincent Ascension at Peyton Manning Childrens HospitalVerified postcodeIndianapolis, United States· Recruiting
- Investigative Clinical Research of IndianaVerified postcodeNoblesville, United States· Recruiting
- University of KentuckyVerified postcodeLexington, United States· Recruiting
- University of Maryland Greenebaum Comprehensive Cancer CenterVerified postcodeBaltimore, United States· Recruiting
- Beth Israel Deaconess Medical CenterVerified postcodeBoston, United States· Recruiting
- Henry Ford Health SystemVerified postcodeDetroit, United States· Recruiting
- Cancer and Hematology Centers of Western MichiganVerified postcodeGrand Rapids, United States· Recruiting
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States· Recruiting
Common questions
What is Diffuse Large B-cell Lymphoma (DLBCL)?
DLBCL is a common and fast-growing type of cancer that affects white blood cells called lymphocytes.
What is the 'standard of care' treatment?
This refers to the best and most widely accepted treatment available for a condition, based on current medical knowledge.
Why are some patients previously untreated and others have relapsed?
Previously untreated means they haven't had treatment for their lymphoma yet. Relapsed means the lymphoma came back after treatment, and refractory means it didn't respond to treatment.
What is a Phase 3 study?
A Phase 3 study is a large study that compares a new treatment with existing standard treatments to see if it's better and safe enough to be approved for general use.
Will I know which treatment I'm receiving?
In some parts of the study, you might not know whether you're receiving the new medicine or the standard one. This is done to ensure the results are unbiased and fair.
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?
Discussion
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