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)

• ClinicalTrials.gov Identifier: NCT04182204
• Recruitment Status: Active, not recruiting
• First Posted: December 2, 2019
• Last Update Posted: May 30, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Diffuse Large B-Cell Lymphoma	Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin	Phase 3

Detailed Description:

The safety run-in stage (Stage 1) will assess the safety of polatuzumab vedotin plus rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) in 10 participants. The randomized controlled trial (RCT) (Stage 2) will compare Pola-R-GemOx versus R-GemOx alone using overall survival (OS). This is an event-driven trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: In stage 1 participants are all assigned to one group. In stage 2 participants are assigned to two groups in parallel for the duration of the study.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: February 7, 2020
• Estimated Primary Completion Date: September 30, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: 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.; Drug: Rituximab; Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.; Other Name: Mabthera; Rituxan; Drug: Gemcitabine; Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.; Drug: Oxaliplatin; Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
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.	Drug: 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.; Drug: Rituximab; Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.; Other Name: Mabthera; Rituxan; Drug: Gemcitabine; Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.; Drug: Oxaliplatin; Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
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.	Drug: Rituximab; Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.; Other Name: Mabthera; Rituxan; Drug: Gemcitabine; Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.; Drug: Oxaliplatin; Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.

Outcome Measures

Primary Outcome Measures :

1. Stage 1: Percentage of Participants with Adverse Events (AEs) [ Time Frame: From baseline until 90 days after last dose (up to approximately 55 months) ]
2. Stage 2: Overall Survival (OS) [ Time Frame: From randomization in RCT up to approximately 34 months ]
   Overall survival was defined as the time from the date of randomization to the date of death from any cause.

Secondary Outcome Measures :

1. Stage 1: Percentage of Participants with Peripheral Neuropathy [ Time Frame: From baseline up to approximately 71 months ]
   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.
2. Stage 1: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions [ Time Frame: From baseline up to approx. 55 months ]
3. Stage 1: Polatuzumab Vedotin Dose Intensity [ Time Frame: From baseline up to approx. 55 months ]
   Dose intensity is defined as the ratio of actual dose administered versus intended dose.
4. Stage 1: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline [ Time Frame: Baseline (Day 1 of Stage 1) ]
5. 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) ]
6. Stage 1: Percentage of Participants with Complete Response (CR) [ Time Frame: From baseline up to approximately 55 months ]
   CR was defined as complete metabolic response assessed by the investigator through PET-CT Scan according to Lugano 2014 response criteria.
7. Stage 1: Percentage of Participants with Objective Response (OR) [ Time Frame: From baseline up to approximately 55 months ]
   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.
8. Stage 1: Best Overall Response (BOR) [ Time Frame: From baseline up to approximately 71 months ]
   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
9. Stage 1: Progression Free Survival (PFS) [ Time Frame: From baseline up to approximately 71 months ]
   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.
10. Stage 1: Overall Survival (OS) [ Time Frame: From baseline up to approximately 71 months ]
    OS is defined as the time from enrollment to death from any cause.
11. Stage 1: Event Free Survival (EFS) [ Time Frame: From baseline up to approximately 71 months ]
    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).
12. Stage 2: Percentage of Participants with Objective Response (OR) [ Time Frame: From randomization in RCT until up to 34 months ]

    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.

13. Stage 2: Percentage of Participants with Complete Response (CR) [ Time Frame: From randomization in RCT until up to 34 months ]

    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.

14. Stage 2: Best Overall Response (BOR) [ Time Frame: From randomization in RCT until up to 49 months ]
    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
15. Stage 2: Progression Free Survival (PFS) [ Time Frame: From randomization in RCT until up to 49 months ]
    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.
16. Stage 2: Duration of Response (DOR) [ Time Frame: From randomization in RCT until up to 49 months ]
    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.
17. Stage 2: Event Free Survival (EFS) [ Time Frame: From randomization in RCT until up to 49 months ]
    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.
18. 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) ]
    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.
19. 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) ]
    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.
20. 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) ]
    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.
21. 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) ]
    Time to progression is defined as the time from randomization to the first documentation of a 3-point decrease (clinically meaningful change) from baseline.
22. 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) ]
    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.
23. Stage 2: Percentage of Participants with Adverse Events (AEs) [ Time Frame: From randomization in RCT until up to 34 months ]
24. Stage 2: Percentage of Participants with Polatuzumab Vedotin Dose Interruptions and Dose Reductions [ Time Frame: From baseline in RCT up to approx. 34 months ]
25. Stage 2: Polatuzumab Vedotin Dose Intensity [ Time Frame: From baseline in RCT up to approx. 34 months ]
    Dose intensity is defined as the ratio of actual dose administered versus intended dose.
26. Stage 2: Percentage of Participants with Peripheral Neuropathy [ Time Frame: From randomization in RCT until up to 49 months ]
    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.
27. Stage 2: Percentage of Participants with Anti-drug Antibodies (ADAs) to Polatuzumab Vedotin at Baseline [ Time Frame: Baseline (Day 1 of Stage 2) ]
28. 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) ]

Other Outcome Measures:

1. 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) ]
   Re-classified as 'Other Pre-specified' due to sparse PK sampling, to support population PK analysis of the data which is an exploratory analysis.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

Memorial Regional Hospital

Hollywood, Florida, United States, 33021

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

Jacksonville, Florida, United States, 32256

Memorial Cancer Institute at Memorial West

Pembroke Pines, Florida, United States, 33028

United States, Michigan

St. Joseph Mercy - Brighton

Brighton, Michigan, United States, 48114

St. Joseph Mercy - Canton

Canton, Michigan, United States, 48188

St. Joseph Mercy - Chelsea

Chelsea, Michigan, United States, 48118-1370

IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center

Ypsilanti, Michigan, United States, 48197

United States, Missouri

Oncology Hematology Associates - Springfield

Springfield, Missouri, United States, 65807

United States, Nebraska

Nebraska Cancer Specialists; Oncology Hematology West, PC

Omaha, Nebraska, United States, 68130

United States, New Jersey

MSKCC at Basking Ridge

Basking Ridge, New Jersey, United States, 07920

Memorial Sloan Kettering - Monmouth

Middletown, New Jersey, United States, 07748

Memorial Sloan Kettering Cancer Center at Bergen

Montvale, New Jersey, United States, 07645

United States, New York

MSKCC @ Commack

Commack, New York, United States, 11725

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States, 10604

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Memorial Sloan Kettering Nassau

Uniondale, New York, United States, 11553

United States, Texas

Millennium Research & Clinical Development

Houston, Texas, United States, 77090

Brazil

Hospital Sao Rafael - HSR

Salvador, BA, Brazil, 41253-190

Liga Norte Riograndense Contra O Câncer

Natal, RN, Brazil, 59040150

Hospital das Clinicas - UFRGS

Porto Alegre, RS, Brazil, 90035-903

Hospital das Clinicas - FMUSP

Sao Paulo, SP, Brazil, 05403-900

Canada, Ontario

London Health Sciences Centre

London, Ontario, Canada, N6A 4L6

Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site

St. Catharines, Ontario, Canada, L2R 7C6

Canada, Quebec

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada, H4A 3J1

Centre hospitalier regional de Trois-Rivieres

Trois-Rivieres, Quebec, Canada, G8Z 3R9

China

Hu Nan Provincial Cancer Hospital

Changsha, China, 410006

West China Hospital - Sichuan University

Chengdu City, China, 610047

Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

Guangzhou City, China, 510060

Zhujiang Hospital, Southern Medical University

Guangzhou, China, 510280

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, China, 330019

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, China, 530021

Institute of Hematology and Hospital of Blood Disease

Tianjin City, China, 300020

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan City, China, 430022

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China, 710061

Finland

Oulu University Hospital; Oncology

Oulu, Finland, 90029

Tampere University Hospital; Dept of Oncology

Tampere, Finland, 33520

France

Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny

Creteil, France, 94010

CHU de Nîmes - Hôpital Carémeau

Nimes, France, 30029

Hopital De Haut Leveque; Hematologie Clinique

Pessac, France, 33604

Centre Henri Becquerel; Service Hématologie

Rouen, France, 76038

ICANS

Strasbourg, France, 67200

Hopital Bretonneau; Hematologie Therapie Cellulaire

TOURS Cedex, France, 37044

Germany

Gemeinschaftsklinikum Mittelrhein gGmbH; Ev. Stift St. Martin

Koblenz, Germany, 56068

Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie

Luebeck, Germany, 23538

Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

Ulm, Germany, 89081

Greece

Laiko General Hospital; Hematology Clinic

Athens, Greece, 115 27

Attiko Hospital; Haematology Clinic

Athens, Greece, 124 62

India

All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital; Department of Oncology

New Delhi, Delhi, India, 110029

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400013

Tata Medical Center

Kolkata, WEST Bengal, India, 700160

Ireland

St James' Hospital; Cancer Clinical Trials Office

Dublin, Ireland

Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia

Modena, Emilia-Romagna, Italy, 41123

Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

Roma, Lazio, Italy, 00133

Osp. San Raffaele; Dip. Di Oncoematologia

Milano, Lombardia, Italy, 20132

Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

Bari, Puglia, Italy, 70124

USL 4 di Prato - Nuovo Ospeale di Prato

Prato, Toscana, Italy, 59100

Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova

Padova, Veneto, Italy, 35128

Korea, Republic of

Pusan National University Hospital

Busan, Korea, Republic of, 602-739

Chungnam National University Hospital

Daejeon, Korea, Republic of, 35015

Gyeongsang National University Hospital

Gyeongsangnam-do, Korea, Republic of, 52727

Seoul National University Bundang Hospital

Seongnam-si, Korea, Republic of, 463-707

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 003-722

Mexico

Health Pharma Professional Research

Cdmx, Mexico CITY (federal District), Mexico, 03100

Hospital de Especialidades Centro Medico Nacional La Raza; Haematology

Mexico City, Mexico CITY (federal District), Mexico, 02990

Instituto Nacional de Cancerologia; Oncology

Mexico City, Mexico, 14080

Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

Badalona, Barcelona, Spain, 08915

Hospital Universitario de Canarias;servicio de Hematologia

La Laguna, Tenerife, Spain, 38320

Hospital Univ. 12 de Octubre; Servicio de Hematologia

Madrid, Spain, 28041

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

Salamanca, Spain, 37007

Hospital Universitario Dr. Peset; Servicio de Hematologia

Valencia, Spain, 46017

Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, Sweden, 751 85

Turkey

Sakarya Universitesi Egitim ve Arastirma Hastanesi

Adapazari/Sakarya, Turkey, 54100

Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

Ankara, Turkey, 06200

Akdeniz Uni School of Medicine; Hematology

Antalya, Turkey, 07059

Istanbul Uni Istanbul Medical Faculty

Istanbul, Turkey, 34093

Istanbul University Cerrahpasa Medical Faculty; Hematology Department

Istanbul, Turkey, 34098

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey, 41380

Amerikan HAstanesi Onkoloji Birimi Te?vikiye

Ni?anta??, Turkey, 34365

United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

Kings College Hospital

London, United Kingdom, SW9 8RR

Nottingham City Hospital; Dept of Haematology

Nottingham, United Kingdom, NG5 1PB

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT04182204
• Other Study ID Numbers: MO40598; 2018-003727-10 ( EudraCT Number )
• First Posted: December 2, 2019
• Last Update Posted: May 30, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:

Lymphoma; Large B-Cell; Diffuse

Additional relevant MeSH terms:

Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Rituximab; Gemcitabine; Oxaliplatin; Polatuzumab vedotin; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Immunoconjugates