Clinical Trial TitleTrial of Mosunetuzumab as Consolidation Therapy in Participants with DLBCL Following First-Line Immunochemotherapy and as Monotherapy or in Combination with Polatuzumab Vedotin in Elderly/Unfit Participants with Previously Untreated DLBCL
National Clinical Trial Number:NCT03677154
Clinical Trial Protocol Description:
Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Diffuse B-cell lymphoma has been found in people of all age groups, but it is most commonly found in people who are middle-aged or elderly. This is a treatment trial for subjects whose disease has returned (relapsed) or did not respond (refractory) to at least one line of treatment or there are other medical complications that do not allow the subject to tolerate full dose chemotherapy for treatment.
Mosunetuzumab is an investigational drug being tested for DLBCL. It is a monoclonal antibody that may kill lymphoma cells by recruiting and activating immune cells. Polatuzumab vedotin is an antibody drug conjugate, which is an antibody to which a chemotherapy drug is attached. Polatuzumab vedotin targets a specific marker called CD79b (or the CD79b antigen) that is found on the surface of tumor cells and it uses this target to deliver the chemotherapy drug to the tumor.
There are 3 treatment groups in this study: Cohorts A, B or C. Cohort A participants will receive mosunetuzumab (IV; into the vein) if they have had some response to their initial chemotherapy treatment for DLBCL, but there is still evidence of remaining disease. Cohort B participants will receive mosunetuzumab IV if they have never been treated for their DLBCL and they are 60 years old or older and are unable to receive the full amount of chemotherapy for DLBCL. Cohort C participants will receive mosunetuzumab (SC; injection under the skin) in combination with polatuzumab vedotin IV if they have never been treated for their DLBCL and they are 65 old or older and are able to receive the full amount of chemotherapy for DLBCL
Treatment with mosunetuzumab may last for up to 5 months in Cohort A and up to 13 months in Cohorts B and C. The length of study visits may vary depending on which tests are required at that visit. Shorter visits may last 1-2 hours, but some of the longer visits could take up to 9 hours.
Participants may be admitted to the hospital for monitoring for 1 day following their treatments depending on how they tolerated the first infusions or injection and their general health condition.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older and adequate hematologic and organ function.
- Have at least one bi-dimensionally measurable nodal lesion.
- Have the ability and willingness to comply with the study protocol procedures.
- Have a life expectancy of at least 6 months.
You will be excluded from the study if any of the following criteria apply to you:
- Have Transformed lymphoma or Central Nervous System lymphoma.
- Have had treatment with mosunetuzumab or have had a prior stem cell transplant (autologous and allogeneic).
- Have a history of progressive multifocal leukoencephalopathy (PML).
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.