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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 2026 → Jan 2027
See other at-risk trials from Weill Medical College of Cornell University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion pushed from Sep 2026 to Jan 2027
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study sites revised (4)
  2. Primary completion date: Sep 2025 to Sep 2026
    • Study completion date: Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 24 words
    • Site contacts updated at 1 of 4 sites
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Study sites: 1 to 4
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 5 entries
    v7
  5. Primary completion date: Dec 2023 to Sep 2025
    • Study completion date: Jun 2024 to Sep 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2021 to Sep 24, 2021
    • Site details revised
    v5
  2. Start date: Aug 2021 to Oct 2021v4
  3. Start date: May 2021 to Aug 2021v3
  4. Start date: Jan 2021 to May 2021
    • Site contact updated
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04679012
Lead Sponsor Weill Medical College of Cornell University
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Richter Syndrome, Chronic Lymphocytic Leukemia
Related terms Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov