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Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
NCT04679012 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Rituximab
- DRUG Etoposide
- DRUG Prednisone
- DRUG Polatuzumab Vedotin
Study Locations (4)
New York
- Mount Sinai- Icahn School of Medicine — New York
- Columbia University Medical Center — New York
- Weill Cornell Medicine — New York
Ohio
- Ohio state University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04679012
The ClinicalTrials.gov registry entry for NCT04679012 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 679 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04679012 reports 4 study locations spanning 2 distinct geographic areas — top geographies include New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04679012 about?
NCT04679012 is a clinical study titled "Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation". 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. W...
What is the current status of trial NCT04679012?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-09-24. Estimated completion is 2027-09.
What conditions does trial NCT04679012 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Richter Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04679012?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), Etoposide (DRUG), Prednisone (DRUG), Polatuzumab Vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04679012?
This trial is sponsored by Weill Medical College of Cornell University, which has 679 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04679012 being conducted?
This trial has 4 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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