Actively Recruiting
Phase II Study of Polatuzumab Vedotin Combined With Chemotherapy in Richter's Transformation
Led by Weill Medical College of Cornell University · Updated on 2025-10-07
20
Participants Needed
4
Research Sites
52 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 research aims to evaluate the effectiveness and safety of Polatuzumab vedotin combined with a modified chemoimmunotherapy regimen in people with Richter's Transformation, a type of aggressive lymphoma that develops from chronic lymphocytic leukemia or small lymphocytic lymphoma. This open-label, single arm phase II trial is designed to study this combination treatment given the need for new therapy options in this condition. The study is sponsored by Weill Medical College of Cornell University and assesses important outcomes including remission rates and survival. Participants will receive Polatuzumab vedotin along with six cycles of a chemotherapy combination called R-EPCH, which includes rituximab, etoposide, prednisone, cyclophosphamide, and hydroxydaunorubicin. The treatment is given every 21 days, with Polatuzumab vedotin administered by intravenous infusion on the first day of each cycle. The chemotherapy drugs are given either by IV or orally as appropriate. This regimen is administered on an inpatient basis following established dosing protocols. During the study, participants will be closely monitored weekly during treatment and then followed for one year after treatment ends or until disease progression or unacceptable side effects occur. After this 52-week follow-up, participants will continue to be observed every 12 weeks for two additional years to assess survival and subsequent treatments. Researchers will evaluate remission rates at the end of treatment, overall response, progression-free and overall survival, and safety measures throughout the study.
CONDITIONS
Brief 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 (CLL) or small lymphocytic lymphoma (SLL) with biopsy-proven Richter's Transformation to diffuse large B-cell lymphoma subtype
- Age 18 years or older
- Ability to sign informed consent
- Willingness and ability to follow 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 1.5 cm or larger in longest diameter
- Adequate bone marrow function: absolute neutrophil count ≥ 1000 cells/uL, hemoglobin ≥ 7 g/dL, platelet count ≥ 30,000 cells/uL (growth factor or transfusion support allowed if given at least 7 days prior to enrollment)
- Adequate organ function: bilirubin ≤ 1.5 times upper limit of normal (Gilbert's disease exceptions), creatinine clearance > 30 ml/min/1.73m2, ejection fraction ≥ 50%
- For women of childbearing potential: agreement to use effective contraception during treatment and for 12 months after last dose, and negative pregnancy test within 7 days prior to enrollment
- For men: agreement to use contraception or abstinence during treatment and for 5 months after last dose, and not donate sperm during this time
You will not qualify if you...
- Richter's Transformation not of diffuse large B-cell lymphoma subtype (e.g., Hodgkin lymphoma, PLL)
- Prior therapy targeting Richter's Transformation
- Starting targeted agents such as BTKi, venetoclax, or PI3K before enrollment (continuation allowed as bridge but no new/additional therapy)
- Allogeneic stem cell transplant for CLL within 6 months
- Active or presumed secondary malignancy at enrollment (exceptions for certain skin cancers)
- Known HIV positive status
- Active hepatitis B or C infection (positive PCR)
- Baseline grade 2 or higher peripheral neuropathy
- Severe allergic reactions to humanized or murine monoclonal antibodies
- Central nervous system involvement with large cell transformation
- Significant uncontrolled diseases affecting protocol compliance
- Severe cardiovascular disease (e.g., advanced heart failure, recent myocardial infarction, unstable arrhythmias)
- Active infections requiring IV antibiotics or hospitalization within 4 weeks before treatment
- Major surgery within 4 weeks before treatment start (except superficial or laparoscopic lymph node biopsies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 19 weeks
Participants receive Polatuzumab vedotin combined with chemotherapy drugs including rituximab, etoposide, prednisone, cyclophosphamide, and hydroxydaunorubicin. Treatment is given on an inpatient basis every 21 days for 6 cycles.
6 inpatient visits every 21 days
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.
K
Katherine Greig, R.N.
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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