Clinical Trial

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

Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-07-16; most recent amendment 2025-09-23.
Status change: Recruiting → Active, Not Recruiting 2025-05-01
Trial Details
NCT Number NCT04479267
Lead Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute (NCI)
Conditions 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
Enrollment 8 participants
Start Date 2020-08-21
Primary Completion 2025-06-19 (estimated)
Study Completion 2026-07-19 (estimated)
Updated on ClinicalTrials.gov 2025-09-29