Study on Brentuximab Vedotin with Lenalidomide and Rituximab for Treating Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
ClinicalTrials ID:NCT04404283
This clinical trial is testing whether adding brentuximab vedotin to the standard treatment of lenalidomide and rituximab can better treat diffuse large B-cell lymphoma (DLBCL) that has returned or not improved with previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
Participants in this study have diffuse large B-cell lymphoma (DLBCL) that has either come back or not improved with treatment. The trial is investigating if adding brentuximab vedotin to the usual treatment of lenalidomide and rituximab works better than using the two drugs alone. Participants will be randomly assigned to receive either brentuximab vedotin or a placebo, which looks like the drug but has no active medicine. The study is 'blinded,' meaning neither the participants nor their doctors will know who receives the actual drug or the placebo. All participants will receive rituximab and lenalidomide, which are standard treatments for DLBCL.
Eligibility Criteria
Inclusion Criteria
- Have relapsed or hard-to-treat diffuse large B-cell lymphoma (DLBCL) or transformed DLBCL.
- Have tried at least two previous treatments that did not work.
- Cannot have a stem cell transplant or CAR-T therapy due to medical reasons or other issues like cost or availability.
- Must provide a recent tumor sample for testing.
- Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have cancer that shows up on specific scans and is measurable by certain criteria.
Exclusion Criteria
- Have had another cancer within the last two years or still have signs of a previous cancer.
- Have a history of a specific brain disease called progressive multifocal leukoencephalopathy (PML).
- Have active brain or spinal cord disease related to the cancer, unless it has been treated and stable for at least three months.
- Have an uncontrolled severe infection within two weeks before starting the study.
- Have not completed other cancer treatments at least three weeks before starting the study, unless the disease has progressed.
- Have previously been treated with brentuximab vedotin or lenalidomide, unless it was more than six months ago.
- Are currently on certain medications that suppress the immune system or other cancer treatments.
- Have had a recent stroke, heart attack, or severe heart problems within six months before starting the study.
- Have severe heart failure or significant nerve damage.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Central Alabama Research | 35209 | Birmingham | Alabama |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| University of California Davis Medical Center | 95817 | Sacramento | California |
| Florida Cancer Specialists | 34135 | Bonita Springs | Florida |
| Florida Cancer Specialists | 34211 | Bradenton | Florida |
| Florida Cancer Specialists | 33909 | Cape Coral | Florida |
| Florida Cancer Specialists | 32117 | Daytona Beach | Florida |
| Florida Cancer Specialists | 33905 | Fort Myers | Florida |
| Florida Cancer Specialists | 33908 | Fort Myers | Florida |
| Florida Cancer Specialists | 34102 | Naples | Florida |
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