Actively Recruiting
Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Led by Christine Ryan · Updated on 2026-01-07
70
Participants Needed
5
Research Sites
468 weeks
Total Duration
On this page
Sponsors
C
Christine Ryan
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma transformed to diffuse large B-cell lymphoma consistent with Richter's Transformation
- Specific cohort criteria for treatment groups regarding prior therapies and disease status
- Age 18 years or older
- ECOG performance status of 0-2
- Adequate organ and marrow function as defined for each treatment cohort
- Prior allogeneic transplant allowed under specific conditions
- Willingness to use effective contraception or abstain during and after treatment
- Ability to understand and sign informed consent
You will not qualify if you...
- Hodgkin variant transformation of CLL
- Prior exposure to any study drugs specific to their treatment cohort
- Recent treatment with investigational agents or certain therapies within defined timeframes
- Prior CAR T-cell therapy within 30 days
- Unrecovered significant toxicity from prior anti-cancer therapy
- Bulky cervical adenopathy causing airway risk
- History of other active malignancies except specified exceptions
- Peripheral neuropathy grade >1 for polatuzumab vedotin recipients
- History of severe immune-related adverse events
- History or current central nervous system disease involvement
- History of certain lung diseases or active pneumonitis
- Uncontrolled effusions requiring frequent drainage
- Prior solid organ transplantation
- History of hemophagocytic lymphohistiocytosis
- Active or history of autoimmune diseases with exceptions
- Use of systemic immunosuppressants excluding specified exceptions
- Severe allergic reactions to monoclonal antibodies without desensitization
- Recent major surgery or trauma
- History of HIV or HTLV-1 infection with restrictions
- Active viral hepatitis or liver disease without control
- Recent major infection or live vaccinations
- Significant cardiovascular disease or heart failure as defined
- Known hypersensitivity to study drugs or excipients
- History of bleeding disorders or recent major bleeding
- Inability to comply with study requirements
- Pregnancy or breastfeeding
- Any condition contraindicating investigational drug use
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
C
Celeste Carey, MS
CONTACT
C
Christine Ryan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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