Clinical Trial Summary (S2207)
Adding the Drug Zanubrutinib to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Earlier Treatment
What is the purpose of this clinical trial?
This study tests a drug for treating certain types of large B-cell lymphoma (LBCL) that came back or did not respond to previous treatment.
Researchers will test adding the study drug, zanubrutinib (Brukinsa), to a usual treatment for LBCL. They’ll compare zanubrutinib plus the usual treatment to the usual treatment alone.
The usual treatment uses 2 drugs:
- tafasitamab (Monjuvi)
- lenalidomide (Revlimid)
All of the drugs in the study are approved by the Food and Drug Administration (FDA) for treating some types of lymphoma.
This trial is set up to find out:
- If adding zanubrutinib to usual treatment can lower the chance of LBCL getting worse
- If people who have specific changes in their cancer cells are more likely to benefit from zanubrutinib
Why is this trial important?
This trial is a chance to improve treatment options for lymphoma that came back or did not respond to previous treatment.
The trial may also help doctors learn about using certain information in cancer cells to match patients with treatments. If the study treatment works, the trial could help doctors know which patients in the future might benefit most from receiving it.
Who can be in this trial?
This trial is for adults, age 18 or older, with large B-cell lymphoma, high grade B-cell lymphoma, transformed lymphoma, or follicular lymphoma.
This trial may be for people who:
- Have lymphoma that returned after treatment or did not respond to previous treatment
- May have had a stem cell transplant or CAR T-cell therapy in previous treatment
This trial is not for people who:
- Will have a stem cell transplant
- Already had treatment with any drugs used in this study
- Are pregnant or breastfeeding
What treatments will I get?
A computer will randomly assign you to one of 2 study groups:
You’ll have an equal chance of being in the usual treatment group or the usual treatment + zanubrutinib group. Your doctor won’t have control over which group you’re assigned to. This helps make sure the study results are fair and reliable.
How long will I be in the trial?
In total, you will be in the study for 3 years.
You may get up to 13 cycles of treatment in the study. This will take about 1 year to complete.
After treatment, you will have follow-up visits with the study team until 3 years after you started the study.
Are there costs? Will I get paid?
Zanubrutinib is provided free in the study. Ask your health care provider and insurance provider about what other costs will and won’t be covered in this study. You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search using the national clinical trial number: NCT05890352
- For a list of trial locations, visit swog.org/NCI-S2207
Key Information
Information your doctor or trial navigator may need to help you.
Protocol Number
S2207
NCT Number
NCT05890352
Full Trial Title
Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapsed/Refractory Large B-Cell Lymphoma
Trial Sponsors
SWOG Cancer Research Network
Publication Date