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NCT04182204CompletedPhase 3

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Source: ClinicalTrials.gov · Last updated 22 Dec 2025

Brief summary (registry, in English)

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 (RCT).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
270 (actual)
First submitted
18 Nov 2019
Start date
7 Feb 2020
Primary completion date
29 Nov 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04182204
EU CT number
2024-512537-33-00
EudraCT number
2018-003727-10

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 270
  • From 7 Feb 2020 to the primary completion date, 29 Nov 2024
  • 64 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 or CAR T-cell therapy at time of recruitment
  • Richter's transformation or prior CLL
  • 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
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug

Other illness

  • 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

Lab values

  • 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
  • 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
  • Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug

Other

  • Contraindication to rituximab, gemcitabine or oxaliplatin
  • Peripheral neuropathy assessed to be \> Grade 1 according to NCI CTCAE v5.0
  • Primary or secondary central nervous system (CNS) lymphoma

Who the study is looking for

  • 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 did not respond to or that progressed during therapy or progressed within 6 months (\< 6 months) of prior therapy)
  • At least one (≥ 1) line of prior systemic therapy:
  • Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; In such cases, salvage chemotherapy (e.g., rituximab, dexamethasone, cytarabine, and cisplatin \[R-DHAP\] and rituximab, ifosfamide, carboplatin, and etoposide phosphate \[R-ICE\]) will be counted as one line of therapy and conditioning chemotherapy (e.g., BEAM) 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; In such cases, salvage chemotherapy (e.g., R-DHAP and R-ICE) will be counted as one line of therapy and conditioning chemotherapy (e.g., carmustine, etoposide, cytarabine, and melphalan \[BEAM\]) followed by allogeneic HSCT will be counted as a separate line of therapy
  • Participants may have undergone CAR T-cell therapy prior to recruitment. In such cases, cell collection, conditioning chemotherapy, and infusion will be counted as one line of therapy.
  • Local therapies (e.g., radiotherapy) will not be considered as lines of treatment
  • For participants with a history of the transformation of indolent disease to DLBCL, it is preferred that participants have received at least one treatment for the transformed lymphoma. However, if there are cases where the participants have received an anthracycline-containing chemotherapy regimen (such as R-CHOP) for the indolent lymphoma only, then these participants can be considered as eligible.
  • 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,

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (64)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
Hospital das Clinicas - UFRGS
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Porto AlegreBrazilUnknown status
Hospital Sao Rafael - HSR
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SalvadorBrazilUnknown status
Hospital das Clinicas FMUSP
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São PauloBrazilUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Niagara Health Systems - St. Catherines General Site
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St. CatharinesCanadaUnknown status
Centre Hospitalier Regional de Trois-Rivieres
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Trois-RivièresCanadaUnknown status
Hu Nan Provincial Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Cancer Center, Sun Yat-sen University of Medical Sciences
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GuangzhouChinaUnknown status
The 1st Affiliated Hospital of Nanchang Unversity
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NanchangChinaUnknown status
Guangxi Cancer Hospital of Guangxi Medical University
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NanningChinaUnknown status
Institute of Hematology and Hospital of Blood Disease
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TianjinChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Universitario De Canarias
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La LagunaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainCompleted
Oulu University Hospital
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OuluFinlandUnknown status
Tampere University Hospital
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TampereFinlandUnknown status
Assistance Publique Hopitaux De Paris
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CreteilFranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Henri Becquerel
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RouenFranceCompleted
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceCompleted
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceCompleted
Kings College Hospital
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LondonUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
St James Hospital
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DublinIrelandUnknown status
Tata Medical Center
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KolkataIndiaUnknown status
Tata Memorial Hospital
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MumbaiIndiaUnknown status
All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital
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New DelhiIndiaUnknown status
Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
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BariItalyCompleted
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyCompleted
Azienda Ospedaliera di Padova
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PadovaItalyCompleted
Azienda USL Toscana Centro
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PratoItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Chungnam National University Hospital
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DaejeonSouth KoreaUnknown status
Gyeongsang National University Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Instituto Nacional de Cancerologia
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Distrito FederalMexicoUnknown status
Health Pharma Professional Research
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Mexico CityMexicoUnknown status
Hospital de Especialidades Centro Medico Nacional La Raza
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Mexico CityMexicoUnknown status
IHA Hematology Oncology Consultants - Ann Arbor
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Ann ArborUnited StatesUnknown status
MSKCC at Basking Ridge
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Basking RidgeUnited StatesUnknown status
Cancer Specialists
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JacksonvilleUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center at Bergen
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MontvaleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Memorial Cancer Institute at Memorial West
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Pembroke PinesUnited StatesUnknown status
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesUnknown status
Sakarya Universitesi Egitim ve Arastirma Hastanesi
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Adapazari/SakaryaTurkey (Türkiye)Unknown status
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
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AnkaraTurkey (Türkiye)Unknown status
Akdeniz Uni School of Medicine
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AntalyaTurkey (Türkiye)Unknown status
Istanbul Uni Istanbul Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Kocaeli Universitesi Tip Fakultesi
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KocaeliTurkey (Türkiye)Unknown status
Amerikan HAstanesi Onkoloji Birimi Te?vikiye
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Ni?anta??Turkey (Türkiye)Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.