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
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.
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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