- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04182204
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 (POLARGO)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: MO40598 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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BA
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Salvador, BA, Brazil, 41253-190
- Hospital Sao Rafael - HSR
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RN
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Natal, RN, Brazil, 59040150
- Liga Norte Riograndense Contra O Cancer
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RS
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Porto Alegre, RS, Brazil, 90035-903
- Hospital das Clinicas - UFRGS
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SP
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Sao Paulo, SP, Brazil, 05403-010
- Hospital das Clinicas - FMUSP
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Health Sciences Centre
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St. Catharines, Ontario, Canada, L2R 7C6
- Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre - Glen Site
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Trois-Rivieres, Quebec, Canada, G8Z 3R9
- Centre hospitalier regional de Trois-Rivieres
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Changsha, China, 410006
- Hu Nan Provincial Cancer Hospital
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Chengdu City, China, 610047
- West China Hospital - Sichuan University
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Guangzhou City, China, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
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Nanchang, China, 330019
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanning City, China, 530021
- Guangxi Cancer Hospital of Guangxi Medical University
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Tianjin City, China, 300020
- Institute of Hematology and Hospital of Blood Disease
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Wuhan City, China, 430023
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Xi'an, China, 710061
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Oulu, Finland, 90029
- Oulu University Hospital; Oncology
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Tampere, Finland, 33520
- Tampere University Hospital; Dept of Oncology
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Creteil, France, 94010
- Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny
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Nimes, France, 30029
- CHU de Nîmes - Hôpital Carémeau
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Pessac, France, 33604
- Hopital De Haut Leveque; Hematologie Clinique
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Rouen, France, 76038
- Centre Henri Becquerel; Service Hématologie
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Strasbourg, France, 67200
- ICANS
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TOURS Cedex, France, 37044
- Hopital Bretonneau; Hematologie Therapie Cellulaire
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Koblenz, Germany, 56068
- Gemeinschaftsklinikum Mittelrhein gGmbH; Ev. Stift St. Martin
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Luebeck, Germany, 23538
- Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie
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Ulm, Germany, 89081
- Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
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Athens, Greece, 124 62
- Attiko Hospital; Haematology Clinic
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Athens, Greece, 115 27
- Laiko General Hospital; Hematology Clinic
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Delhi
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New Delhi, Delhi, India, 110029
- All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital; Department of Oncology
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Maharashtra
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Mumbai, Maharashtra, India, 400013
- Tata Memorial Hospital
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WEST Bengal
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Kolkata, WEST Bengal, India, 700160
- Tata Medical Center
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Dublin, Ireland, D08NHY1
- St James' Hospital; Cancer Clinical Trials Office
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Emilia-Romagna
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Modena, Emilia-Romagna, Italy, 41123
- Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia
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Lazio
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Roma, Lazio, Italy, 00133
- Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
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Puglia
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Bari, Puglia, Italy, 70124
- Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
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Toscana
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Prato, Toscana, Italy, 59100
- USL 4 di Prato - Nuovo Ospeale di Prato
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Veneto
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Padova, Veneto, Italy, 35128
- Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
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Busan, Korea, Republic of, 602-739
- Pusan National University Hospital
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Daejeon, Korea, Republic of, 35015
- Chungnam National University Hospital
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Gyeongsangnam-do, Korea, Republic of, 52727
- Gyeongsang National University Hospital
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Seongnam-si, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
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Mexico City, Mexico, 14080
- Instituto Nacional de Cancerologia; Oncology
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Mexico CITY (federal District)
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Cdmx, Mexico CITY (federal District), Mexico, 03100
- Health Pharma Professional Research
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Mexico City, Mexico CITY (federal District), Mexico, 02990
- Hospital de Especialidades Centro Medico Nacional La Raza; Haematology
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Madrid, Spain, 28041
- Hospital Univ. 12 de Octubre; Servicio de Hematologia
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Salamanca, Spain, 37007
- Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
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Valencia, Spain, 46017
- Hospital Universitario Dr. Peset; Servicio de Hematologia
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Barcelona
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Badalona, Barcelona, Spain, 08915
- Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
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Tenerife
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La Laguna, Tenerife, Spain, 38320
- Hospital Universitario de Canarias;servicio de Hematologia
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Adapazari/Sakarya, Turkey, 54100
- Sakarya Universitesi Egitim ve Arastirma Hastanesi
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Ankara, Turkey, 06200
- Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
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Antalya, Turkey, 07059
- Akdeniz Uni School of Medicine; Hematology
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Istanbul, Turkey, 34093
- Istanbul Uni Istanbul Medical Faculty
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Istanbul, Turkey, 34098
- Istanbul University Cerrahpasa Medical Faculty; Hematology Department
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Kocaeli, Turkey, 41380
- Kocaeli Universitesi Tip Fakultesi
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Ni?anta??, Turkey, 34365
- Amerikan HAstanesi Onkoloji Birimi Te?vikiye
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Glasgow, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Centre
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London, United Kingdom, SW9 8RR
- Kings College Hospital
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Nottingham, United Kingdom, NG5 1PB
- Nottingham City Hospital; Dept of Haematology
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Florida
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital
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Jacksonville, Florida, United States, 32256
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
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Pembroke Pines, Florida, United States, 33028
- Memorial Cancer Institute at Memorial West
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Michigan
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Ypsilanti, Michigan, United States, 48197
- IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center
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Nebraska
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Omaha, Nebraska, United States, 68130
- Nebraska Cancer Specialists; Oncology Hematology West, PC
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- MSKCC at Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering - Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Cancer Center at Bergen
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New York
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Commack, New York, United States, 11725
- MSKCC @ Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Cancer Center at Westchester
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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:
- 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Other Names:
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
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Experimental: 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.
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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 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Other Names:
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
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Active Comparator: 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.
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Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Other Names:
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Stage 1: Percentage of Participants with Adverse Events (AEs)
Time Frame: From baseline until 90 days after last dose (up to approximately 55 months)
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From baseline until 90 days after last dose (up to approximately 55 months)
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Stage 2: Overall Survival (OS)
Time Frame: From randomization in RCT up to approximately 34 months
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Overall survival was defined as the time from the date of randomization to the date of death from any cause.
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From randomization in RCT up to approximately 34 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Stage 1: Percentage of Participants with Peripheral Neuropathy
Time Frame: From baseline up to approximately 71 months
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Peripheral neuropathy will be measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item Scale (FACT-GOG/Ntx12).
FACT-GOG/Ntx12 is a 12-item self-reported questionnaire designed to measure chemotherapy-induced peripheral neuropathy and contains 12 items, covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy.
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From baseline up to approximately 71 months
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Stage 1: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions
Time Frame: From baseline up to approx. 55 months
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From baseline up to approx. 55 months
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Stage 1: Polatuzumab Vedotin Dose Intensity
Time Frame: From baseline up to approx. 55 months
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Dose intensity is defined as the ratio of actual dose administered versus intended dose.
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From baseline up to approx. 55 months
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Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline
Time Frame: Baseline (Day 1 of Stage 1)
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Baseline (Day 1 of Stage 1)
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Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline
Time Frame: Baseline up until Month 2 of the Post-Treatment Follow-up period (up to approx. 55 months)
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Baseline up until Month 2 of the Post-Treatment Follow-up period (up to approx. 55 months)
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Stage 1: Percentage of Participants with Complete Response (CR)
Time Frame: From baseline up to approximately 55 months
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CR was defined as complete metabolic response assessed by the investigator through PET-CT Scan according to Lugano 2014 response criteria.
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From baseline up to approximately 55 months
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Stage 1: Percentage of Participants with Objective Response (OR)
Time Frame: From baseline up to approximately 55 months
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OR is defined as complete metabolic response (CR) or partial metabolic response (PR) and will be assessed by the investigator through PET-CT scan according to Lugano 2014 response criteria.
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From baseline up to approximately 55 months
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Stage 1: Best Overall Response (BOR)
Time Frame: From baseline up to approximately 71 months
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BOR is defined as the best response recorded from the start of treatment until end of treatment (based on PET-CT or CT data) according to Lugano 2014 response criteria, determined by the investigator
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From baseline up to approximately 71 months
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Stage 1: Progression Free Survival (PFS)
Time Frame: From baseline up to approximately 71 months
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PFS is defined as the time from enrollment to the first occurrence of disease progression (as determined by the investigator according to Lugano 2014 response criteria) or death.
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From baseline up to approximately 71 months
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Stage 1: Overall Survival (OS)
Time Frame: From baseline up to approximately 71 months
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OS is defined as the time from enrollment to death from any cause.
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From baseline up to approximately 71 months
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Stage 1: Event Free Survival (EFS)
Time Frame: From baseline up to approximately 71 months
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EFS is defined as the time from enrollment to the first occurrence of disease progression or relapse, death due to any cause or initiation of any non-protocol-specified antilymphoma treatment (NALT).
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From baseline up to approximately 71 months
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Stage 2: Percentage of Participants with Objective Response (OR)
Time Frame: From randomization in RCT until up to 34 months
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OR is defined as CR or PR and will be assessed by an Independent review committee through PET-CT scan according to Lugano 2014 response criteria. OR will also be assessed by the investigator using Response alone (not including PET data) and will consider complete response instead of complete metabolic response. |
From randomization in RCT until up to 34 months
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Stage 2: Percentage of Participants with Complete Response (CR)
Time Frame: From randomization in RCT until up to 34 months
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CR will be assessed by an Independent review committee through PET-CT scan according to Lugano 2014 response criteria. CR will also be assessed by the Investigator using Response (not including PET data) and will consider complete response instead of complete metabolic response. |
From randomization in RCT until up to 34 months
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Stage 2: Best Overall Response (BOR)
Time Frame: From randomization in RCT until up to 49 months
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BOR is defined as the best response recorded from the start of treatment until end of treatment (based on PET-CT or CT data) according to Lugano 2014 response criteria, determined by the investigator
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From randomization in RCT until up to 49 months
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Stage 2: Progression Free Survival (PFS)
Time Frame: From randomization in RCT until up to 49 months
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PFS is defined as the time from the time of randomization to the first occurrence of disease progression (as determined by the investigator according to Lugano 2014 response criteria) or death.
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From randomization in RCT until up to 49 months
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Stage 2: Duration of Response (DOR)
Time Frame: From randomization in RCT until up to 49 months
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DOR will be assessed in patients who had an OR, as determined by the investigator, using Lugano 2014 response criteria.
DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.
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From randomization in RCT until up to 49 months
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Stage 2: Event Free Survival (EFS)
Time Frame: From randomization in RCT until up to 49 months
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EFS is defined as the time from enrollment to the first occurrence of disease progression or relapse, death due to any cause or initiation of NALT.
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From randomization in RCT until up to 49 months
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Stage 2: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score
Time Frame: Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties.
The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Key scales included physical functioning, and fatigue, and GHS.
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Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Stage 2: Time to Deterioration in Physical Functioning and Fatigue
Time Frame: Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Time to deterioration in physical functioning and fatigue is defined as the time from randomization to the first documentation of a 10-point decrease in EORTC QLQ-C30 physical functioning and fatigue scales from baseline.
The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties.
The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).
Key scales included physical functioning, and fatigue, and GHS.
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Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Stage 2: Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score
Time Frame: Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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The FACT-Lym is a validated health-related quality of life (HRQoL) instrument used specifically in patients with lymphoma.
It is composed of the 27-item FACT-general questionnaire (FACT-G), which measures health-related quality of life in patients undergoing any type of cancer therapy, plus the 15-item Lymphoma-Specific Subscale (FACT-Lym LYMS), which assesses the HRQoL impacts of more lymphoma-specific symptoms.
Each item of the FACT-Lym is answered using a 5-point scale ranging from 0 = "not at all" to 4 = "very much".
0 = Not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = Very much.
FACT-LYM total score can be calculated and higher scores are reflective of better HRQoL.
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Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Stage 2: Time to Progression in Lymphoma Symptoms According to FACT-Lym Subscale
Time Frame: Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Time to progression is defined as the time from randomization to the first documentation of a 3-point decrease (clinically meaningful change) from baseline.
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Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Stage 2: Change from Baseline in Peripheral Neuropathy According to FACT/GOG-NTX-12 Subscale Score
Time Frame: Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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FACT/GOG-Ntx12 is a 12-item self-reported questionnaire designed to measure chemotherapy-induced peripheral neuropathy and contains 12 items, covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy.
It is answered using a 5-point scale ranging from 0 = "not at all" to 4 = "very much".
0 = Not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = Very much.
FACT/GOG-Ntx12 subscale scores can be calculated with higher scores reflective of a better outcome.
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Baseline (Cycle 1 [each cycle is 21 days]), Cycles 2, 3, 5, and 7; 28 days after last dose; and every 2 months during follow up (up to 49 months)
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Stage 2: Percentage of Participants with Adverse Events (AEs)
Time Frame: From randomization in RCT until up to 34 months
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From randomization in RCT until up to 34 months
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Stage 2: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions
Time Frame: From baseline in RCT up to approx. 34 months
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From baseline in RCT up to approx. 34 months
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Stage 2: Polatuzumab Vedotin Dose Intensity
Time Frame: From baseline in RCT up to approx. 34 months
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Dose intensity is defined as the ratio of actual dose administered versus intended dose.
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From baseline in RCT up to approx. 34 months
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Stage 2: Percentage of Participants with Peripheral Neuropathy
Time Frame: From randomization in RCT until up to 49 months
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Peripheral neuropathy will be measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-Item Scale (FACT-GOG/Ntx12).
FACT-GOG/Ntx12 is a 12-item self-reported questionnaire designed to measure chemotherapy-induced peripheral neuropathy and contains 12 items, covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy.
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From randomization in RCT until up to 49 months
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Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline
Time Frame: Baseline (Day 1 of Stage 2)
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Baseline (Day 1 of Stage 2)
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Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline
Time Frame: Baseline (Day 1 of Stage 2) up until Month 2 of the Post-Treatment Follow-up period (up to approx. 34 months)
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Baseline (Day 1 of Stage 2) up until Month 2 of the Post-Treatment Follow-up period (up to approx. 34 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stage 1: Observed Plasma Concentrations of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (acMMAE) and Unconjugated MMAE (ng/mL)
Time Frame: Pre- and post-dose (infusion duration=90 minutes [min]) on Cycle 1 Day 1 and Cycle 4 Day 1 (Cycle length=21 days)
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Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.
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Pre- and post-dose (infusion duration=90 minutes [min]) on Cycle 1 Day 1 and Cycle 4 Day 1 (Cycle length=21 days)
|
Stage 2: Observed Plasma Concentrations of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (acMMAE) and Unconjugated MMAE (ng/mL)
Time Frame: Pre- and post-dose (infusion duration=90 minutes [min]) on Cycle 1 Day 1 and Cycle 4 Day 1 (Cycle length=21 days)
|
Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.
|
Pre- and post-dose (infusion duration=90 minutes [min]) on Cycle 1 Day 1 and Cycle 4 Day 1 (Cycle length=21 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immunoconjugates
- Oxaliplatin
- Rituximab
- Gemcitabine
- Polatuzumab vedotin
Other Study ID Numbers
- MO40598
- 2018-003727-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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