Actively Recruiting
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
Led by Weill Medical College of Cornell University · Updated on 2025-10-07
20
Participants Needed
4
Research Sites
309 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates the effectiveness and safety of Polatuzumab vedotin plus infusional chemoimmunotherapy containing rituximab, etoposide, prednisone, cyclophosphamide and hydroxydaunorubicin. This is a single arm study. Enrolled patients will receive up to six cycles (21-day cycles) of therapy. While on study, subjects will be monitored weekly until end of treatment, then followed for 52 weeks or until disease progression or discontinuation due to toxicity or death. After completion of the 52-week follow-up/End of study visit, Subjects will be followed for an additional 104 week period, with an assessment occurring every 12 weeks to evaluate survival outcomes and next line of treatments only.
CONDITIONS
Official Title
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma with biopsy-proven Richter's Transformation to DLBCL subtype
- Age 18 years or older
- Ability to sign informed consent
- Willingness and ability to comply with study procedures
- Life expectancy of at least 24 weeks
- Eastern Cooperative Oncology Group performance status of 2 or less
- Measurable disease with at least one lymph node �3e 1.5 cm in longest diameter
- Adequate bone marrow function with absolute neutrophil count �3e= 1000 cells/uL
- Hemoglobin �3e= 7 g/dL
- Platelet count �3e= 30,000 cells/uL
- Adequate organ function with total bilirubin �3c= 1.5 times upper limit of normal (exceptions for Gilbert's disease)
- Creatinine clearance �3e 30 ml/min/1.73m2
- Ejection fraction �3e= 50% by echocardiogram or MUGA scan
- For women of childbearing potential: agreement to use effective contraception or abstinence during treatment and for 12 months after last dose, with negative pregnancy test within 7 days prior to enrollment
- For men: agreement to abstain or use condoms plus another contraceptive method during treatment and for 5 months after last dose, and not to donate sperm during this period
You will not qualify if you...
- Richter's Transformation not of DLBCL subtype (e.g., Hodgkin lymphoma, PLL)
- Prior therapy targeting Richter's Transformation
- Starting targeted agents like BTKi, venetoclax, or PI3K before enrollment (continuation allowed as bridging under conditions)
- Allogeneic stem cell transplant within 6 months before study entry
- Active or presumed secondary malignancy at enrollment (exceptions for certain treated cancers)
- Known HIV positive status
- Active hepatitis B or C infection (except certain hepatitis B antibody positive cases with monitoring)
- Baseline Grade 2 or higher peripheral neuropathy
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Known or clinical central nervous system involvement with transformed large cells
- Significant uncontrolled diseases affecting protocol compliance or results
- Serious cardiovascular disease (e.g., NYHA Class III/IV, recent heart attack, unstable arrhythmias or angina)
- Active infections requiring treatment or recent major infections
- Major surgery within 4 weeks before starting treatment (except certain lymph node biopsies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mount Sinai- Icahn School of Medicine
New York, New York, United States, 10029
Actively Recruiting
2
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
4
Ohio state University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Amelyn Rodriguez, R.N.
CONTACT
K
Katherine Greig, R.N.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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