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  • Cancer Type: Malignant Hematology
  • Study Type: Treatment
  • NCT#: NCT04182204
  • Phase: Phase III
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  • Overview

    Study Title:

    A Phase III, Open-Label, Multicenter, Randomized Study Evaluating The Safety And Efficacy Of Polatuzumab Vedotin In Combination With RituximabI Plus Gemcitabine Plus Oxaliplatin (R-Gemox) Versus R-Gemox Alone In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma


    This study is currently being conducted at Moffitt's Memorial Healthcare site in Hollywood, Florida. This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial.


    To evaluate the safety and tolerability of Pola-R-GemOx as a combination therapy, To evaluate the efficacy of Pola-R-GemOx compared with R-GemOx alone

  • Inclusion Criteria

      Inclusion Criteria:
    • Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL
    • Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that progressed during therapy or progressed within 6 months (> At least one (≥ 1) line of prior systemic therapy:
    • Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; chemotherapy followed by consolidative autologous HSCT will be counted as one line of therapy
    • Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; chemotherapy followed by allogeneic HSCT will be counted as one line of therapy
    • Local therapies (e.g., radiotherapy) will not be considered as lines of treatment
    • At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
    • Adequate hematological function
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs
    • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
  • Exclusion Criteria

      Exclusion Criteria:
    • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
    • Contraindication to rituximab, gemcitabine or oxaliplatin
    • Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0
    • Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks
    • Planned autologous or allogenic stem cell transplantation at time of recruitment
    • Primary or secondary central nervous system (CNS) lymphoma
    • Richter's transformation or prior CLL
    • Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
    • Vaccination with a live vaccine within 4 weeks prior to treatment
    • Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
    • Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug

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