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Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion date: Jun 19, 2025 to Jul 19, 2026v7
  2. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Enrollment target: estimated 49 to confirmed 8
    • Primary completion date: Nov 15, 2025 to Jun 19, 2025
    • Study completion date: Nov 15, 2026 to Jun 19, 2025
    • Site details revised
  3. Primary completion date: Nov 15, 2023 to Nov 15, 2025
    • Study completion date: Nov 15, 2023 to Nov 15, 2026
    • Study site revised
    v5
  4. Primary and study completion dates: Dec 1, 2022 to Nov 15, 2023v4 Show 4 more changesShow less
    • Study sites: 2 to 1
    • Eligibility criteria expanded, about 47 words
    • Study description expanded, about 14 words
    • Study title shortened, about 4 words
  5. Study sites: 1 to 2
    • Eligibility criteria expanded, about 39 words
    v3
  6. Start date changed from estimate of Jul 25, 2020 to Aug 21, 2020v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Polatuzumab vedotin is a monoclonal antibody that works by binding with cancer cells and releasing another chemotherapy drug, called monomethyl auristatin E, into the cell causing the cancer cells to die or stop growing. Chemotherapy drugs, such as rituximab, cyclophosphamide, doxorubicin, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving polatuzumab vedotin with combination chemotherapy may work better in treating patients with double or triple hit lymphoma compared to combination chemotherapy alone.
Trial Details
NCT Number NCT04479267
Lead Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Diffuse Large B-Cell Lymphoma, High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements, Double Expressor Lymphoma, High-grade B-cell Lymphoma
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov