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DFHCC-23-429: Glofitamab with or without polatuzumab vedotin or atezolizumab for Richter's Transformation

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.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

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.

Incentives

Study participant will not be charged for study drugs glofitamab, polatuzumab vedotin, atezolizumab

In-person visits:
20-40
Phone or online visits:
0-5
Total length of participation:
Up to 9 months of treatment

Looking for Specific Volunteers

Able to participate:

  • You have been diagnosed with chronic lymphocytic leukemia with Richter's Transformation
  • You have adequate organ (liver, heart, kidney) and bone marrow function

Not eligible if:

  • You have been diagnosed with the Hodgkin variant transformation of CLL
  • You have previously treated with either an anti-CD20 bispecific antibody, polatuzumab vedotin, or atezolizumab therapy
  • You have a current or past history of Central Nervous System disease, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease
  • You have a current or past history of autoimmune disease
  • You equire systemic immunosuppressive therapy for an ongoing medical condition

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Deborah Stephens
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia, Lymphoma)

IRB Number

24-0160

ClinicalTrials.gov

NCT06043674

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