NCT04679012 · Weill Medical College of Cornell University
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
What this study 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 treatment group$1 study. Enrolled patients will receive up to six cycles (21-day cycles) of therapy.
View original scientific description
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.
Interventions
DRUG
Polatuzumab Vedotin
Polatuzumab vedotin will be administered as an IV infusion at 1.8mg/kg on Day 1 of each cycle, every 21 days.
DRUG
Rituximab
Rituximab will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
DRUG
Etoposide
Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
DRUG
Prednisone
Prednisone will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. Prednisone will be given orally.
DRUG
Cyclophosphamide
Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
DRUG
Hydroxydaunomycin
Hydroxydaunomycin will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
Primary outcome measures
Complete metabolic remission/complete remission (CMR/CR) rate of subjects at end of treatment (EOT)
Time frame: 19 weeks
Percentage of subjects who achieve CMR/CR on study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject must have confirmed diagnosis of CLL based upon 2018 International Workshop on CLL (IwCLL) criteria, with biopsy proven Richter's Transformation to a DLBCL subtype.
- Subject must be ≥18 years of age.
- Subject must be able to sign informed consent
- Ability and willingness to comply with the study protocol procedures
- Life expectancy of at least 24 weeks
- Subject must have an Eastern Cooperative Oncology Group performance status of ≤2.
- Subject must have measurable disease with atleast on LN\>- 1.5cm in longest diameter
- Subject must have adequate bone marrow function and meet the below thresholds prior to treatment.
- Absolute neutrophil count of ≥1000 cell/uL
- Hemoglobin ≥ 7 g/dL
- Platelet count ≥ 30,000 cells/uL
- Subject must have adequate organ function and meet the thresholds below:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). Subjects with Gilbert's disease will be granted exception to this rule.
- Creatinine cl
Where
- New York, New York
- Columbus, Ohio
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2025 · Source of record for eligibility and locations