A Phase 2 Study of Glofitamab as Monotherapy or in Combination With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Christine Ryan
Summary
This research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT). The names of the study drugs involved in this research study are: * Glofitamab (a T-cell bispecific humanized monoclonal antibody) * Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody) * Polatuzumab vedotin (an antibody-drug conjugate) * Pirtobrutinib (a selective inhibitor of BTK) * Atezolizumab (a humanized immunoglobulin monoclonal antibody) * Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody)
Description
This is an open-label, multicenter phase II study to evaluate the efficacy and safety of glofitamab as monotherapy and in combination with polatuzumab vedotin, pirtobrutinib, or atezolizumab for participants with Richter's Transformation (RT) that has transformed from chronic lymphocytic leukemia (CLL). The U.S. Food and Drug Administration (FDA) has not approved glofitamab, obinutuzumab, polatuzumab vedotin, pirtobrutinib or atezolizumab for RT, but each drug has been approved for other uses. Glofitamab has been approved by the FDA for certain people with diffuse large B-cell lymphoma (DLBC…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per IW-CLL 2018 criteria with biopsy proven transformation to diffuse large B-cell lymphoma (DLBCL), consistent with Richter's Transformation. The diagnostic sample must be reviewed by the treating institution. Tumor sample may be obtained by core needle or excisional surgical biopsy. A fresh biopsy is encouraged, but an archival sample is acceptable if the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue bloc…
Interventions
- DrugGlofitamab
"2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol.
- DrugObinutuzumab
Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol.
- DrugPolatuzumab Vedotin
Antibody-drug conjugate, administered via intravenous infusion per protocol.
- DrugAtezolizumab
Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol.
- DrugTocilizumab
For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol.
- DrugPirtobrutinib
Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol.
Locations (5)
- Winship Cancer Institute at Emory UniversityAtlanta, Georgia
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- The University of North Carolina at Chapel HillChapel Hill, North Carolina
- The Ohio State University Comprehensive Cancer CenterColumbus, Ohio