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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03274492
Ethics application status
Date submitted
5/09/2017
Date registered
7/09/2017
Date last updated
17/06/2020

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Michigan
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Austria
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Innsbruck
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Austria
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Krems
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Haine-Saint-Paul
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Belgium
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Liège
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Beijing
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Changchun City
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China
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Fuzhou City
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China
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Guangzhou
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China
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Hangzhou
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China
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Nanjing
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Shanghai City
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China
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Shanghai
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China
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Tianjin City
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China
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Tianjing
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China
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Wuhan City
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China
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Zhengzhou
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava - Poruba
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Czechia
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Prague
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Amiens
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Angers
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Avignon
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Bordeaux
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Caen
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CHAMBERY Cedex
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Clermont Ferrand
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Corbeil Essonnes
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Creteil
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Dijon
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Grenoble
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La Roche Sur Yon
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La Tronche
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Le Chesnay
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Le Mans Cedex 02
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France
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Lille
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Limoges
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Lyon
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Metz
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Montpellier
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Mulhouse
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Nantes
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Nice
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France
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Nimes
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France
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Paris
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France
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Perpignan
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Pessac
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France
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Pierre Benite
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France
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Poitiers
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France
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Quimper Cedex
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France
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Rennes
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Rouen
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France
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St Brieuc
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France
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St Priest en Jarez
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France
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Strasbourg
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France
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Toulouse
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France
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Tours
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France
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Vandoeuvre Les Nancy
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France
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Vannes Cedex
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dessau-Roßlau
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Germany
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Essen
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Koblenz
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Germany
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Mainz
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Germany
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München
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Germany
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Münster
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Israel
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Roslyn Palmerston North
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Italy
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Abruzzo
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Italy
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Emilia-Romagna
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
State/province [124] 0 0
Hokkaido
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Japan
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Hyogo
Country [126] 0 0
Japan
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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/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
Reference Study ID Number: GO39942 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

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