Clinical Trial TitleA Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
National Clinical Trial Number:NCT04404283
Clinical Trial Protocol Description:
This study is testing to see if brentuximab vedotin, lenalidomide, and rituximab given together work to treat diffuse large B-cell lymphoma (DLBCL) that has come back or didn’t get better with your last treatment. The study is designed to compare lenalidomide and rituximab given together against all 3 drugs given together.
Brentuximab vedotin is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 parts.
- Antibody: Antibodies are part of subject’s immune system. Usually they help protect subject from getting sick. In brentuximab vedotin, they are using an antibody designed to find and stick to the cancer cells in subject’s body.
- Drug: The drug is the part of the ADC that kills cells. The cell-killing part of brentuximab vedotin is a chemotherapy drug called monomethyl auristatin E (MMAE).
There are 2 treatment groups in the study: Brentuximab + rituximab + lenalidomide or Brentuximab placebo + rituximab + lenalidomide. The study drugs will be given in 21-day cycles. If your cancer stays the same or gets better, you may keep getting the study drugs. After you have stopped getting the study drugs, we will ask you to have follow up visits or follow-up phone calls about every 3 months for a year. After a year, we will ask you to have follow-up visits every 6 months until the study is closed.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have relapsed or refractory diffuse and transformed large B-cell lymphoma after receiving at least 2 prior treatment regimens.
- Are HSCT or CAR-T ineligible.
- Have adequate organ function.
You will be excluded from the study if any of the following criteria apply to you:
- Have a medical history of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.
- Have a history of progressive multifocal leukoencephalopathy (PML).
- Have had a history of stroke or transient ischemic attack), unstable angina, myocardial infarction within 6 months prior to the first dose of study drugs.
- Have congestive heart failure.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.