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
- Diseases
- Diffuse large B-cell lymphoma
- 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
Sites (64)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Unknown status |
| Hospital das Clinicas - UFRGS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Rafael - HSR Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Hospital das Clinicas FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Niagara Health Systems - St. Catherines General Site Coordinator of this site? Confirm its status | St. Catharines | Canada | Unknown status |
| Centre Hospitalier Regional de Trois-Rivieres Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Hu Nan Provincial Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Cancer Center, Sun Yat-sen University of Medical Sciences Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The 1st Affiliated Hospital of Nanchang Unversity Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Guangxi Cancer Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Institute of Hematology and Hospital of Blood Disease Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Hospital Universitario De Canarias Coordinator of this site? Confirm its status | La Laguna | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Hospital Universitario Dr. Peset Aleixandre Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Unknown status |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil | France | Completed |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Completed |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Completed |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Completed |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nottingham City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| St James Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Tata Medical Center Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Completed |
| Azienda USL Toscana Centro Coordinator of this site? Confirm its status | Prato | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Gyeongsangnam-do | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Instituto Nacional de Cancerologia Coordinator of this site? Confirm its status | Distrito Federal | Mexico | Unknown status |
| Health Pharma Professional Research Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Hospital de Especialidades Centro Medico Nacional La Raza Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| IHA Hematology Oncology Consultants - Ann Arbor Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| MSKCC at Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Cancer Specialists Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center at Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Cancer Institute at Memorial West Coordinator of this site? Confirm its status | Pembroke Pines | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
| Sakarya Universitesi Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Adapazari/Sakarya | Turkey (Türkiye) | Unknown status |
| Abdurrahman Yurtarslan Onkoloji Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Akdeniz Uni School of Medicine Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Istanbul Uni Istanbul Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Kocaeli Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Amerikan HAstanesi Onkoloji Birimi Te?vikiye Coordinator of this site? Confirm its status | Ni?anta?? | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.