This study is recruiting people who have been diagnosed with chronic lymphocytic leukemia (CLL) that has transformed to aggressive lymphoma called Richter's Transformation (RT)? Its purpose is to evaluate the drug glofitamab by itself or in combination with polatuzumab vedotin or atezolizumab as possible treatments for this diagnosis.
Before being enrolled in the study you will undergo screening procedures, including a physical exam, blood tests, a PET-CT scan, a biopsy to collect tumor tissue and a bone marrow biopsy. If you are eligible for the study, you will be enrolled in the study in one of three intravenous drug regimens over twelve 21-day treatment cycles: 1) Monotherapy: You will be treated at UNC with obinutuzumab and glofitamab 2) Combination A: You will be treated at UNC with obinutuzumab and glofitamab and polatuzumab vedotin 3) Combination B: You will be treated at UNC with obinutuzumab and glofitamab and atezolizumab During study visits, the study drugs will be infused into your veins and you will undergo physical exams. During certain visits, you may undergo other procedures such as blood tests, urine tests and tumor PET-CT scans. Follow-up visits will occur every 3 months for months 10-24 (starting from the beginning of treatment), and every 6 months for for months 25-60 (starting from the beginning of treatment). They may include other procedures such as blood tests, urine tests and tumor PET-CT scans. Throughout the study blood and tissue specimens will be collected in a Biobank and and shared with an outside lab or collaborator for analysis. The specimens will not be identifiable, or traceable back to you. You will be asked if you want to participate in optional research studies involving additional lymph node biopsies on treatment and if your disease progresses.
Study participant will not be charged for study drugs glofitamab, polatuzumab vedotin, atezolizumab
Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Deborah Stephens
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Leukemia, Lymphoma)
24-0160