Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03274492




Registration number
NCT03274492
Ethics application status
Date submitted
5/09/2017
Date registered
7/09/2017
Date last updated
11/04/2024

Titles & IDs
Public title
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
Scientific title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
Secondary ID [1] 0 0
2017-002023-21
Secondary ID [2] 0 0
GO39942
Universal Trial Number (UTN)
Trial acronym
POLARIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Polatuzumab Vedotin
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Vincristine Placebo
Treatment: Drugs - Prednisone
Treatment: Drugs - Polatuzumab vedotin Placebo

Experimental: R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin - Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m^2) IV, cyclophosphamide 750 mg/m^2 IV, and doxorubicin 50 mg/m^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8.

Placebo Comparator: R-CHOP plus Polatuzumab Vedotin Placebo - Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m^2 IV, cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV (maximum 2 milligrams per dose [mg/dose]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8.


Treatment: Drugs: Polatuzumab Vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Vincristine Placebo
Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Polatuzumab vedotin Placebo
Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)
Secondary outcome [1] 0 0
Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Secondary outcome [2] 0 0
Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [2] 0 0
From randomization to first occurrence of disease progression/relapse;or death from any cause;or other primary efficacy reason that leads to initiation of any non-protocol specified antilymphoma treatment(NALT);or residual disease(up to approx 65 months)
Secondary outcome [3] 0 0
Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [3] 0 0
24 months after enrollment (up to approximately 65 months)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
From randomization until death from any cause (up to approximately 65 months)
Secondary outcome [5] 0 0
Percentage of Participants With CR as Assessed by FDG-PET by Investigator
Timepoint [5] 0 0
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Secondary outcome [6] 0 0
Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [6] 0 0
From the date of first occurrence of a documented CR to the date of relapse or death from any cause (up to approximately 65 months)
Secondary outcome [7] 0 0
Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [7] 0 0
From the date of first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause (up to approximately 65 months)
Secondary outcome [8] 0 0
Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [8] 0 0
From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
Secondary outcome [9] 0 0
Time to Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
Timepoint [9] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); treatment completion visit (TCV)/early treatment termination visit (ETTV) (up to approximately 32 weeks); post-treatment follow-up (FU) visit (up to approximately 65 months)
Secondary outcome [10] 0 0
Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
Timepoint [10] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [11] 0 0
Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue
Timepoint [11] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [12] 0 0
Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS
Timepoint [12] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [13] 0 0
EORTC QLQ-C30 Treatment-Related Symptoms Score
Timepoint [13] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [14] 0 0
Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score
Timepoint [14] 0 0
Day 1 of Cycles 1-8 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [15] 0 0
Percentage of Participants With adverse Events (AEs)
Timepoint [15] 0 0
From randomization to the end of study (up to approximately 65 months)
Secondary outcome [16] 0 0
Serum Concentration of Total Polatuzumab Vedotin
Timepoint [16] 0 0
Pre-infusion (0 hour [hr]), 0.5 hr post-infusion (infusion duration=90 minutes [min]) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [17] 0 0
Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])
Timepoint [17] 0 0
0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [18] 0 0
Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Timepoint [18] 0 0
0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [19] 0 0
Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin
Timepoint [19] 0 0
Pre-infusion (0 hr) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)

Eligibility
Key inclusion criteria
- Previously untreated participants with cluster of differentiation 20 (CD20)-positive
DLBCL, including one of the following diagnoses by 2016 World Health Organization
(WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS)
including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich
large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma
kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive
DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or
B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma);
High-grade B-cell lymphoma, NOS

- Availability of archival or freshly collected tumor tissue before study enrolment

- International Prognostic Index (IPI) score of 2-5

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

- Life expectancy greater than or equal to (>/=)12 months

- Left ventricular ejection fraction (LVEF) >/= 50 percent (%) on cardiac multiple-gated
acquisition (MUGA) scan or cardiac echocardiogram (ECHO)

- Adequate hematologic function

- Female participants: Agreement to remain abstinent (refrain from heterosexual
intercourse) or use contraceptive methods and refrain from donating eggs.

- Male participants: agreement to remain abstinent (refrain from heterosexual
intercourse) or use a condom and agreement to refrain from donating sperm.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products

- Contraindication to any of the individual components of CHOP, including prior receipt
of anthracyclines

- Prior organ transplantation

- Current Grade greater than (>) 1 peripheral neuropathy by clinical examination

- Demyelinating form of Charcot-Marie-Tooth disease

- History of indolent lymphoma

- History of follicular lymphoma grade 3B

- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
classical Hodgkin lymphoma (grey-zone lymphoma)

- Primary mediastinal (thymic) large B-cell lymphoma

- Burkitt lymphoma

- Prior treatment with cytotoxic drugs within 5 years of screening for any condition
(example [e.g.], cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody

- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1

- Prior therapy for DLBCL, with the exception of nodal biopsy

- Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than
lymphoma symptom control

- Participants with central nervous system (CNS) lymphoma (primary or secondary
involvement), primary effusion DLBCL, and primary cutaneous DLBCL

- Vaccination with live vaccines within 28 days prior to the start of Cycle 1

- Any investigational therapy within 28 days prior to the start of Cycle 1

- History of other malignancy that could affect compliance with the protocol or
interpretation of results

- Evidence of significant, uncontrolled, concomitant diseases that could affect
compliance with the protocol or interpretation of results, including significant
cardiovascular disease or pulmonary disease

- Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for
diagnosis

- History or presence of an abnormal electrocardiogram (ECG) that is clinically
significant in the investigator's opinion, including complete left bundle branch
block, second- or third-degree heart block, or evidence of prior myocardial infarction

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment or significant
infections within 2 weeks before the start of Cycle 1

- Clinically significant liver disease, including active viral or other hepatitis,
current alcohol abuse, or cirrhosis

- Prior radiotherapy to the mediastinal/pericardial region

- Participants with suspected active or latent tuberculosis

- Positive test results for chronic hepatitis B and hepatitis C infection

- Known history of human immunodeficiency virus (HIV) seropositive status

- Positive results for the human T-lymphotrophic 1 virus (HTLV-1)

- Participants with a history of progressive multifocal leukoencephalopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2024
Actual
Sample size
Target
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital; Haematology - Randwick
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Westmead Hospital; Outpatient Pharmacy University Clinic - Westmead
Recruitment hospital [6] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [7] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [8] 0 0
The University of Adelaide - The Queen Elizabeth Hospital (TQEH) - Woodville South
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Austin Hospital; Cancer Clinical Trials Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
5011 - Woodville South
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
West Virginia
Country [26] 0 0
Austria
State/province [26] 0 0
Innsbruck
Country [27] 0 0
Austria
State/province [27] 0 0
Krems
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Austria
State/province [29] 0 0
Wien
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Haine-Saint-Paul
Country [32] 0 0
Belgium
State/province [32] 0 0
Mont-godinne
Country [33] 0 0
Brazil
State/province [33] 0 0
PR
Country [34] 0 0
Brazil
State/province [34] 0 0
RS
Country [35] 0 0
Brazil
State/province [35] 0 0
SP
Country [36] 0 0
Canada
State/province [36] 0 0
Alberta
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
China
State/province [41] 0 0
Beijing City
Country [42] 0 0
China
State/province [42] 0 0
Beijing
Country [43] 0 0
China
State/province [43] 0 0
Changchun City
Country [44] 0 0
China
State/province [44] 0 0
Fuzhou City
Country [45] 0 0
China
State/province [45] 0 0
Guangzhou City
Country [46] 0 0
China
State/province [46] 0 0
Hangzhou
Country [47] 0 0
China
State/province [47] 0 0
Nanjing City
Country [48] 0 0
China
State/province [48] 0 0
Nanjing
Country [49] 0 0
China
State/province [49] 0 0
Shanghai City
Country [50] 0 0
China
State/province [50] 0 0
Tianjin City
Country [51] 0 0
China
State/province [51] 0 0
Tianjin
Country [52] 0 0
China
State/province [52] 0 0
Wuhan City
Country [53] 0 0
China
State/province [53] 0 0
Zhengzhou
Country [54] 0 0
Czechia
State/province [54] 0 0
Hradec Kralove
Country [55] 0 0
Czechia
State/province [55] 0 0
Olomouc
Country [56] 0 0
Czechia
State/province [56] 0 0
Ostrava - Poruba
Country [57] 0 0
Czechia
State/province [57] 0 0
Prague
Country [58] 0 0
France
State/province [58] 0 0
Amiens
Country [59] 0 0
France
State/province [59] 0 0
Angers
Country [60] 0 0
France
State/province [60] 0 0
Bayonne
Country [61] 0 0
France
State/province [61] 0 0
Besancon
Country [62] 0 0
France
State/province [62] 0 0
Bordeaux
Country [63] 0 0
France
State/province [63] 0 0
Caen
Country [64] 0 0
France
State/province [64] 0 0
CHAMBERY Cedex
Country [65] 0 0
France
State/province [65] 0 0
Creteil
Country [66] 0 0
France
State/province [66] 0 0
Dijon
Country [67] 0 0
France
State/province [67] 0 0
Grenoble
Country [68] 0 0
France
State/province [68] 0 0
La Roche Sur Yon
Country [69] 0 0
France
State/province [69] 0 0
La Tronche
Country [70] 0 0
France
State/province [70] 0 0
Le Mans Cedex 02
Country [71] 0 0
France
State/province [71] 0 0
Lille
Country [72] 0 0
France
State/province [72] 0 0
Limoges
Country [73] 0 0
France
State/province [73] 0 0
Lyon
Country [74] 0 0
France
State/province [74] 0 0
Montpellier
Country [75] 0 0
France
State/province [75] 0 0
Nantes
Country [76] 0 0
France
State/province [76] 0 0
Nice
Country [77] 0 0
France
State/province [77] 0 0
Nimes
Country [78] 0 0
France
State/province [78] 0 0
Paris
Country [79] 0 0
France
State/province [79] 0 0
Perpignan
Country [80] 0 0
France
State/province [80] 0 0
Pessac
Country [81] 0 0
France
State/province [81] 0 0
Pierre Benite
Country [82] 0 0
France
State/province [82] 0 0
Poitiers
Country [83] 0 0
France
State/province [83] 0 0
Quimper Cedex
Country [84] 0 0
France
State/province [84] 0 0
Rennes
Country [85] 0 0
France
State/province [85] 0 0
Rouen
Country [86] 0 0
France
State/province [86] 0 0
St Brieuc
Country [87] 0 0
France
State/province [87] 0 0
St Priest en Jarez
Country [88] 0 0
France
State/province [88] 0 0
Strasbourg
Country [89] 0 0
France
State/province [89] 0 0
Toulouse
Country [90] 0 0
France
State/province [90] 0 0
Tours
Country [91] 0 0
France
State/province [91] 0 0
Vandoeuvre Les Nancy
Country [92] 0 0
France
State/province [92] 0 0
Vannes Cedex
Country [93] 0 0
France
State/province [93] 0 0
Villejuif
Country [94] 0 0
Germany
State/province [94] 0 0
Berlin
Country [95] 0 0
Germany
State/province [95] 0 0
Dessau-Roßlau
Country [96] 0 0
Germany
State/province [96] 0 0
Essen
Country [97] 0 0
Germany
State/province [97] 0 0
Halle
Country [98] 0 0
Germany
State/province [98] 0 0
Heidelberg
Country [99] 0 0
Germany
State/province [99] 0 0
Koblenz
Country [100] 0 0
Germany
State/province [100] 0 0
München
Country [101] 0 0
Germany
State/province [101] 0 0
Münster
Country [102] 0 0
Hong Kong
State/province [102] 0 0
Hong Kong
Country [103] 0 0
Hong Kong
State/province [103] 0 0
Kowloon
Country [104] 0 0
Italy
State/province [104] 0 0
Abruzzo
Country [105] 0 0
Italy
State/province [105] 0 0
Emilia-Romagna
Country [106] 0 0
Italy
State/province [106] 0 0
Liguria
Country [107] 0 0
Italy
State/province [107] 0 0
Lombardia
Country [108] 0 0
Italy
State/province [108] 0 0
Piemonte
Country [109] 0 0
Japan
State/province [109] 0 0
Aichi
Country [110] 0 0
Japan
State/province [110] 0 0
Chiba
Country [111] 0 0
Japan
State/province [111] 0 0
Fukuoka
Country [112] 0 0
Japan
State/province [112] 0 0
Hiroshima
Country [113] 0 0
Japan
State/province [113] 0 0
Hokkaido
Country [114] 0 0
Japan
State/province [114] 0 0
Hyogo
Country [115] 0 0
Japan
State/province [115] 0 0
Kanagawa
Country [116] 0 0
Japan
State/province [116] 0 0
Kumamoto
Country [117] 0 0
Japan
State/province [117] 0 0
Kyoto
Country [118] 0 0
Japan
State/province [118] 0 0
Miyagi
Country [119] 0 0
Japan
State/province [119] 0 0
Osaka
Country [120] 0 0
Japan
State/province [120] 0 0
Tochigi
Country [121] 0 0
Japan
State/province [121] 0 0
Tokyo
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Busan
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Gyeonggi-do
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Seoul
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Yangsan
Country [126] 0 0
New Zealand
State/province [126] 0 0
Auckland
Country [127] 0 0
New Zealand
State/province [127] 0 0
Christchurch
Country [128] 0 0
New Zealand
State/province [128] 0 0
Hamilton
Country [129] 0 0
New Zealand
State/province [129] 0 0
Palmerston North
Country [130] 0 0
Poland
State/province [130] 0 0
?ód?
Country [131] 0 0
Poland
State/province [131] 0 0
Chorzów
Country [132] 0 0
Poland
State/province [132] 0 0
Kraków
Country [133] 0 0
Poland
State/province [133] 0 0
Pozna?
Country [134] 0 0
Poland
State/province [134] 0 0
Warszawa
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Sankt Petersburg
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Tatarstan
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Penza
Country [138] 0 0
Spain
State/province [138] 0 0
Barcelona
Country [139] 0 0
Spain
State/province [139] 0 0
Madrid
Country [140] 0 0
Spain
State/province [140] 0 0
Navarra
Country [141] 0 0
Spain
State/province [141] 0 0
Caceres
Country [142] 0 0
Spain
State/province [142] 0 0
Girona
Country [143] 0 0
Spain
State/province [143] 0 0
Malaga
Country [144] 0 0
Spain
State/province [144] 0 0
Sevilla
Country [145] 0 0
Switzerland
State/province [145] 0 0
Aarau
Country [146] 0 0
Switzerland
State/province [146] 0 0
Basel
Country [147] 0 0
Switzerland
State/province [147] 0 0
Genève
Country [148] 0 0
Taiwan
State/province [148] 0 0
Kaohsiung
Country [149] 0 0
Taiwan
State/province [149] 0 0
Taichung
Country [150] 0 0
Taiwan
State/province [150] 0 0
Tainan
Country [151] 0 0
Taiwan
State/province [151] 0 0
Taipei City
Country [152] 0 0
Taiwan
State/province [152] 0 0
Taipei
Country [153] 0 0
Turkey
State/province [153] 0 0
Ankara
Country [154] 0 0
Turkey
State/province [154] 0 0
Lzmir
Country [155] 0 0
Turkey
State/province [155] 0 0
Te?v?k?ye
Country [156] 0 0
Ukraine
State/province [156] 0 0
Chernihiv Governorate
Country [157] 0 0
Ukraine
State/province [157] 0 0
Kharkiv Governorate
Country [158] 0 0
Ukraine
State/province [158] 0 0
Volhynian Governorate
Country [159] 0 0
United Kingdom
State/province [159] 0 0
Cambridge
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Canterbury
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Leicester
Country [162] 0 0
United Kingdom
State/province [162] 0 0
London
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Manchester
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Newcastle upon Tyne
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Nottingham
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Oxford
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Southhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy,
safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants
with previously untreated diffuse large B-cell lymphoma (DLBCL).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03274492
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03274492