Clinical Trials | S2114: A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-cell Treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-cell Treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with relapsed/ refractory large b-cell lymphoma or Grade IIIB Follicular Lymphoma for a research study. The purpose of the study is to compare usual observation to using the study drugs mosunetuzumab and/or polatuzumab vedotin after CAR T-cell therapy. This study has a screening step known as Step 1 Registration. The purpose of this step is to have a PET-CT scan 30 days after the completion of CAR T-Cell therapy to test if your cancer has changed. If the scan shows that the lymphoma has stayed the same size (Stable Disease or SD) or decreased in size but has not completely gone away (Partial Remission or PR), then you will move on to Step 2 Randomization and the results will help assign you to a study group. If your scans do not show the results needed for this study, your doctor will discuss other options for your care and you will not move on to Step 2 Randomization. In this study after CAR T-cell therapy, you will either get a study drug, a combination of study drugs, or no study drug. You will either get the study drug mosunetuzumab for approximately 4 months, or you will get polatuzumab vedotin for approximately 4 months, or you will get both mosunetuzumab and polatuzumab vedotin for approximately 4 months. After you finish the study treatment, your doctor and study team will watch you for side effects. If the disease has not gotten worse at the end of the study treatment, they will check you every 3 to 6 months for up to 5 years. At these clinic visits, you will have a physical exam, blood tests, and scans. Additional information found here: https://clinicaltrials.gov/study/NCT05633615 For questions, contact: [email protected]