OncoMatch/Clinical Trials/NCT06043674
Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Official title: A Phase 2 Study of Glofitamab as Monotherapy or in Combination With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
Is NCT06043674 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for chronic lymphocytic leukemia.
Treatment: Glofitamab · Obinutuzumab · Polatuzumab Vedotin · Atezolizumab · Tocilizumab · Pirtobrutinib — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — Richter's Transformation
Glofitamab + atezolizumab cohort: Patients with relapsed/refractory RT. Patients are required to have received ≥ 1 prior line of therapy.
Cannot have received: anti-CD20 bispecific antibody
No prior anti-CD20 bispecific antibody is allowed.
Cannot have received: polatuzumab vedotin (polatuzumab vedotin)
No prior polatuzumab vedotin is allowed for patients in the polatuzumab vedotin-containing combination arm.
Cannot have received: atezolizumab (atezolizumab)
No prior atezolizumab therapy is allowed for patients in the atezolizumab-containing combination arm.
Cannot have received: pirtobrutinib (pirtobrutinib)
No prior pirtobrutinib is allowed for patients in the pirtobrutinib-containing arm.
Lab requirements
Blood counts
ANC > 1.0 x10^9/L (growth factor allowed to achieve), unless significant bone marrow involvement; Platelets > 30 x10^9/L (monotherapy/polatuzumab/atezolizumab arms), > 50 x10^9/L (pirtobrutinib arm); Hemoglobin > 8 g/dL (pirtobrutinib arm), independent of transfusion within 7 days of screening, unless bone marrow involvement
Kidney function
Creatinine < 2.0 x ULN or estimated CrCl > 50 ml/min according to Cockcroft/Gault formula
Liver function
Total bilirubin < 1.5 X ULN (up to 3.0 X ULN for Gilbert's Syndrome or resolving autoimmune hemolytic anemia); AST/ALT < 3.0 X ULN (unless documented liver involvement by lymphoma); for pirtobrutinib: AST/ALT < 3.0 X ULN, or < 5.0 X ULN with documented liver involvement by lymphoma; Total bilirubin < 1.5 X ULN or < 3.0 x ULN with documented liver involvement by lymphoma and/or Gilbert's Disease
See protocol for cohort-specific organ and marrow function requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Winship Cancer Institute at Emory University · Atlanta, Georgia
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
- The University of North Carolina at Chapel Hill · Chapel Hill, North Carolina
- The Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06043674 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD20 bispecific antibody, polatuzumab vedotin, atezolizumab disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages