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NCT04679012 · ClinicalTrials.gov registry record · Phase 2

Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

A Phase 2 study of Chronic Lymphocytic Leukemia and Richter Syndrome, sponsored by Weill Medical College of Cornell University.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
4
Study locations

NCT04679012 is a Phase 2 study of Chronic Lymphocytic Leukemia and Richter Syndrome that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 20 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT04679012, a Phase 2 study of Chronic Lymphocytic Leukemia and Richter Syndrome, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
4
Study locations

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

Chronic Lymphocytic Leukemia Richter Syndrome

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

FieldValue
Enrollment Target 20 participants
Start Date 2021-09-24
Est. Completion 2027-09
Phase Phase 2

Sponsor

Weill Medical College of Cornell University

701 total trials

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What the Registry Record Tells You About NCT04679012

The ClinicalTrials.gov registry entry for NCT04679012 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (89% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

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.

NCT04679012 reports 4 study locations spanning 2 distinct geographic areas - top geographies include New York, Ohio.

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.

What interventions are being tested in trial NCT04679012?

The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), Etoposide (DRUG), Prednisone (DRUG), Polatuzumab Vedotin (DRUG).

Who is sponsoring clinical trial NCT04679012?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.