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Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase changed: Phase 1 → Phase 1/2
  2. Re-verified, no change to tracked fields
  3. Primary completion moved earlier from Dec 1, 2026 to Sep 23, 2026 Eligibility criteria expanded, about 28 words · Site details revised · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 28 words
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  4. Enrollment closed, study ongoing Site details revisedv32 Show 1 more changeShow less
    • Site details revised
  5. Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… Eligibility criteria shortened, about 37 wordsv31 Show 1 more changeShow less
    • Eligibility criteria shortened, about 37 words

    See this version in full on ClinicalTrials.gov ↗

Show 29 earlier versionsHide 29 earlier versions
  1. 2 versions Re-verified since Apr 9, 2025, no change to tracked fieldsv29-v30
  2. Enrollment target: 68 to 56 Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy (Procedure), Computed Tomography (Procedure), Cyclophosphamide… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… · Study description expanded, about 4 wordsv28 Show 2 more changesShow less
    • Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy (Procedure), Computed Tomography (Procedure), Cyclophosphamide… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Interventions: Cyclophosphamide (Drug), Doxorubicin (Drug), Etoposide (Drug), Filgrastim (Biological), Polatuzumab Vedotin (Drug), Prednisone (Drug)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy (Procedure), Computed Tomography (Procedure), Cyclophosphamide… Eligibility criteria expanded, about 396 words · Study description expanded, about 149 words · Study arms: 1 to 2 · 1 morev27 Show 4 more changesShow less
    • Eligibility criteria expanded, about 396 words
    • Study description expanded, about 149 words
    • Study arms: 1 to 2
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Suspended to Recruiting Site details revisedv26 Show 1 more changeShow less
    • Site details revised
  5. Enrollment target: 50 to 68v25
  6. Trial status: Recruiting to Suspended Sponsor's reason: The trial is on an enrollment hold while researchers are processing an amendment Site details revisedv24 Show 1 more changeShow less
    • Site details revised
  7. 2 versions Re-verified since Jun 2, 2023, no change to tracked fieldsv22-v23
  8. Eligibility criteria expanded, about 78 wordsv21 See this version in full on ClinicalTrials.gov ↗
  9. Re-verified, no change to tracked fieldsv20
  10. Eligibility criteria expanded, about 6 wordsv19 See this version in full on ClinicalTrials.gov ↗
  11. Trial status: Suspended to Recruiting Site details revisedv18 Show 1 more changeShow less
    • Site details revised
  12. Enrollment target: 18 to 50 Primary completion date: Apr 22, 2022 to Dec 1, 2026 · Completion date: Apr 22, 2027 to Dec 1, 2031v17 Show 2 more changesShow less
    • Primary completion date: Apr 22, 2022 to Dec 1, 2026
    • Completion date: Apr 22, 2027 to Dec 1, 2031
  13. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: Enrollment on hold; likely opening to accrual againv16
  14. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Apr 1, 2023 to Apr 22, 2022 · Completion date: Apr 1, 2023 to Apr 22, 2027 · Site details revised · 1 morev15 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2023 to Apr 22, 2022
    • Completion date: Apr 1, 2023 to Apr 22, 2027
    • Site details revised
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  15. Study Status, Study Description, Arms and Interventions, Eligibilityv14
  16. Re-verified, no change to tracked fieldsv13
  17. Start date changed from estimate of Nov 21, 2020 to Oct 27, 2020v12
  18. Start date: Oct 22, 2020 to Nov 21, 2020v11
  19. Eligibility criteria revisedv10 See this version in full on ClinicalTrials.gov ↗
  20. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 20, 2020 to Oct 22, 2020 · Site details revisedv9 Show 2 more changesShow less
    • Start date: Sep 20, 2020 to Oct 22, 2020
    • Site details revised
  21. Start date: Aug 20, 2020 to Sep 20, 2020v8
  22. Start date: Jul 15, 2020 to Aug 20, 2020v7
  23. Start date: Jun 14, 2020 to Jul 15, 2020v6
  24. Start date: May 14, 2020 to Jun 14, 2020v5
  25. Start date: Apr 14, 2020 to May 14, 2020v4
  26. Start date: Mar 14, 2020 to Apr 14, 2020v3
  27. Start date: Feb 14, 2020 to Mar 14, 2020v2
  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 phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin 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. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.
Trial Details
NCT Number NCT04231877
Lead Sponsor University of Washington
Collaborators: Genentech, Inc.
Conditions Aggressive Non-Hodgkin Lymphoma, ALK-Positive Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-Cell Lymphoma, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma +1 more
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov