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
NCT ID: NCT04182204
Last Updated: 2025-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2020-02-07
2024-11-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pola-R-GemOx (Stage 1)
Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m\^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
Polatuzumab Vedotin
Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
Rituximab
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Gemcitabine
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
Pola-R-GemOx (Stage 2)
Participants will receive polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle administered IV and rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
Polatuzumab Vedotin
Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
Rituximab
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Gemcitabine
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
R-GemOx (Stage 2)
Participants will receive rituximab 375 mg/m\^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m\^2 administered IV and oxaliplatin 100 mg/m\^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
Rituximab
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Gemcitabine
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
Interventions
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Polatuzumab Vedotin
Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
Rituximab
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Gemcitabine
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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,
Exclusion Criteria
* 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 or CAR T-cell therapy 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Cancer Specialists
Jacksonville, Florida, United States
Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, United States
IHA Hematology Oncology Consultants - Ann Arbor
Ann Arbor, Michigan, United States
MSKCC at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Rio Grande do Norte, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
London Health Sciences Centre
London, Ontario, Canada
Niagara Health Systems - St. Catherines General Site
St. Catharines, Ontario, Canada
Centre hospitalier regional de Trois-Rivieres
Trois-Rivières, Quebec, Canada
Hu Nan Provincial Cancer Hospital
Changsha, , China
West China Hospital - Sichuan University
Chengdu, , China
Cancer Center, Sun Yat-sen University of Medical Sciences
Guangzhou, , China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
Institute of Hematology and Hospital of Blood Disease
Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Hopital Henri Mondor
Créteil, , France
Hopital De Haut Leveque
Pessac, , France
Centre Henri Becquerel
Rouen, , France
ICANS
Strasbourg, , France
Hopital Bretonneau
Tours, , France
Universitätsklinikum Ulm
Ulm, , Germany
Laiko General Hospital
Athens, , Greece
Attiko Hospital
Athens, , Greece
Tata Memorial Hospital
Mumbai, Maharashtra, India
All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital
New Delhi, National Capital Territory of Delhi, India
Tata Medical Center
Kolkata, West Bengal, India
St James' Hospital
Dublin, , Ireland
Uni Degli Studi Di Bari, Policlinico
Bari, Apulia, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia
Modena, Emilia-Romagna, Italy
Az. Osp. Uni Ria Policlinico Tor Vergata
Rome, Lazio, Italy
USL 4 di Prato - Nuovo Ospeale di Prato
Prato, Tuscany, Italy
Hospital de Especialidades Centro Medico Nacional La Raza
Mexico City, Mexico CITY (federal District), Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
Instituto Nacional de Cancerologia
Distrito Federal, , Mexico
Pusan National University Hospital
Busan, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Gyeongsang National University Hospital
Gyeongsangnam-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Univ. 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Sakarya Universitesi Egitim ve Arastirma Hastanesi
Adapazari/Sakarya, , Turkey (Türkiye)
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
Ankara, , Turkey (Türkiye)
Akdeniz Uni School of Medicine
Antalya, , Turkey (Türkiye)
Istanbul Uni Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, , Turkey (Türkiye)
Amerikan HAstanesi Onkoloji Birimi Te?vikiye
Ni?anta??, , Turkey (Türkiye)
Kings College Hospital
London, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003727-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO40598
Identifier Type: -
Identifier Source: org_study_id