A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
NCT ID: NCT02257567
Last Updated: 2022-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
331 participants
INTERVENTIONAL
2014-10-15
2021-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Phase II Randomization): Polatuzumab+BR in FL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Arm B (Phase II Randomization): BR in FL
Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with FL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Arm C (Phase II Randomization): Polatuzumab+BR in DLBCL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Arm D (Phase II Randomization): BR in DLBCL
Bendamustine and rituximab will be administered alone (that is, without polatuzumab vedotin) as a control arm in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Arm E (Phase II Expansion): Polatuzumab+BG in FL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Arm F (Phase II Expansion): Polatuzumab+BG in DLBCL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in DLBCL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Cohort 1A (Phase Ib Safety Run-In): Polatuzumab+BR in FL
Polatuzumab vedotin will be administered with bendamustine and rituximab in participants with FL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in DLBCL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Cohort 1B (Phase Ib Safety Run-In): Polatuzumab+BG in FL
Polatuzumab vedotin will be administered with bendamustine and obinutuzumab in participants with FL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Arm G (Phase II NF Cohort): Polatuzumab+BR in DLBCL
In this New Formulation (NF) cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Lyophilized)
Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).
Arm H (Phase II NF Cohort): Polatuzumab+BR in DLBCL
In this NF cohort, Polatuzumab vedotin (lyophilized) will be administered with bendamustine and rituximab in participants with DLBCL.
Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Lyophilized)
Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).
Interventions
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Bendamustine
Bendamustine 90 milligrams per meter-squared (mg/m\^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Liquid)
Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Rituximab
Rituximab standard dose, 375 mg/m\^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
Polatuzumab vedotin (Lyophilized)
Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If the participant has received prior bendamustine, response duration must have been greater than (\>) 1 year (for participants who have relapse disease after a prior regimen)
* At least one bi-dimensionally measurable lesion on imaging scan defined as \>1.5 centimeters (cm) in its longest dimension
* Confirmed availability of archival or freshly collected tumor tissue
* The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology report for central pathology review.
* Life expectancy of at least 24 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Adequate hematological function unless inadequate function is due to underlying disease
Exclusion Criteria
* Contraindication to bendamustine, rituximab, or obinutuzumab
* Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1
* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
* Ongoing corticosteroid use \>30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
* Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
* Prior allogeneic SCT
* Eligibility for autologous SCT
* Grade 3b FL
* History of transformation of indolent disease to DLBCL
* Primary or secondary CNS lymphoma
* Current Grade \>1 peripheral neuropathy
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1
* Suspected or latent tuberculosis
* Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
* Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus
* Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment in the rituximab cohort or within 18 months of last dose in the obinutuzumab cohort
* Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests
* Treatment with chimeric antigen receptor T-cell therapy within 100 days prior to Cycle 1, Day 1
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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Univ of Colorado Canc Ctr
Aurora, Colorado, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States
Emory Univ Winship Cancer Inst
Atlanta, Georgia, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, United States
Regional Cancer Care Associates LLC - Morristown
Morristown, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
West Clinic
Germantown, Tennessee, United States
Swedish Cancer Inst.
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Prince of Wales Hospital; Oncology
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia
Monash Medical Centre; Haematology Research
Clayton, Victoria, Australia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultní nemocnice Ostrava Klinika hematoonkologie
Ostrava, , Czechia
I Interni klinika; Vseobecna fakultni nemocnice
Prague, , Czechia
Chu Site Du Bocage;Hematologie Clinique
Dijon, , France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, , France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, , France
CHU Saint Eloi; Service d'Hématologie Clinique
Montpellier, , France
CHU Lyon Sud - Service Hématologie
Pierre-Bénite, , France
Centre Henri Becquerel; Hematologie
Rouen, , France
HELIOS Klinikum Erfurt - Innere Medizin - 4. Medizinische Klinik, Hämatologie
Erfurt, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Abt. für Hämatologie und Onkologie
Mainz, , Germany
Joh. Wesling Klinikum Minden; Klinik fuer Hämatologie und Onkologie
Minden, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster, , Germany
Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale
Regensburg, , Germany
Semmelweis University, First Dept of Medicine
Budapest, , Hungary
National Institute of Oncology, A Dept of Internal Medicine
Budapest, , Hungary
University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
Debrecen, , Hungary
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Napoli, Campania, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
Milan, Lombardy, Italy
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piedmont, Italy
UMC St. Radboud; Hematology
Nijmegen, , Netherlands
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona; Hematology
Barcelona, , Spain
Hospital Universitario la Paz; Servicio de Hematologia
Madrid, , Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Salamanca, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
Seville, , Spain
Ankara University; Hematology
Ankara, , Turkey (Türkiye)
Dokuz Eylul Uni ; Hematology
Izmir, , Turkey (Türkiye)
Ondokuzmayis University Medical Faculty Heamatology Department
Samsun, , Turkey (Türkiye)
Karadeniz Technical Uni School of Medicine; Hematology
Trabzon, , Turkey (Türkiye)
KINGS COLLEGE HOSPITAL; Commercial R&D Amendments, Kings Health Partners Clinical Trials Office
London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Nottingham City Hospital; Dept of Haematology
Nottingham, , United Kingdom
Southampton General Hospital; Somers Cancer Research Building
Southampton, , United Kingdom
Countries
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References
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Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6.
Bosch F, Kuruvilla J, Vassilakopoulos TP, Maio DD, Wei MC, Zumofen MB, Nastoupil LJ. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 Feb;24(2):105-121. doi: 10.1016/j.clml.2023.09.007. Epub 2023 Sep 28.
Herrera AF, Tracy S, Croft B, Opat S, Ray J, Lovejoy AF, Musick L, Paulson JN, Sehn LH, Jiang Y. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA. Blood Adv. 2022 Mar 22;6(6):1651-1660. doi: 10.1182/bloodadvances.2021006415.
Sehn LH, Hertzberg M, Opat S, Herrera AF, Assouline S, Flowers CR, Kim TM, McMillan A, Ozcan M, Safar V, Salles G, Ku G, Hirata J, Chang YM, Musick L, Matasar MJ. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data. Blood Adv. 2022 Jan 25;6(2):533-543. doi: 10.1182/bloodadvances.2021005794.
Betts KA, Thuresson PO, Felizzi F, Du EX, Dieye I, Li J, Schulz M, Masaquel AS. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma. J Comp Eff Res. 2020 Oct;9(14):1003-1015. doi: 10.2217/cer-2020-0057. Epub 2020 Oct 8.
Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.
Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.
Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, Assouline S, Kim TM, Kim WS, Ozcan M, Hirata J, Penuel E, Paulson JN, Cheng J, Ku G, Matasar MJ. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020 Jan 10;38(2):155-165. doi: 10.1200/JCO.19.00172. Epub 2019 Nov 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-001361-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29365
Identifier Type: -
Identifier Source: org_study_id
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