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NCT03274492 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-05-08

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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. 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
healthy Volunteers
false
maximum Age
80 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Polatuzumab Vedotin
    2. Drug: Rituximab
    3. Drug: Cyclophosphamide
    4. Drug: Doxorubicin
    5. Drug: Vincristine Placebo
    6. Drug: Prednisone
    label
    R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Rituximab
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin
    4. Drug: Vincristine
    5. Drug: Prednisone
    6. Drug: Polatuzumab vedotin Placebo
    label
    R-CHOP plus Polatuzumab Vedotin Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    description
    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
    name
    Polatuzumab Vedotin
    other Names
    1. DCDS4501A; anti-CD79b-VC-MMAE
    type
    DRUG
  2. arm Group Labels
    1. R-CHOP plus Polatuzumab Vedotin Placebo
    2. R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    description
    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
    name
    Rituximab
    type
    DRUG
  3. arm Group Labels
    1. R-CHOP plus Polatuzumab Vedotin Placebo
    2. R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    description
    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
    name
    Cyclophosphamide
    type
    DRUG
  4. arm Group Labels
    1. R-CHOP plus Polatuzumab Vedotin Placebo
    2. R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    description
    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
    name
    Doxorubicin
    type
    DRUG
  5. arm Group Labels
    1. R-CHOP plus Polatuzumab Vedotin Placebo
    description
    Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
    name
    Vincristine
    type
    DRUG
  6. arm Group Labels
    1. R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    description
    Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.
    name
    Vincristine Placebo
    type
    DRUG
  7. arm Group Labels
    1. R-CHOP plus Polatuzumab Vedotin Placebo
    2. R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
    description
    Prednisone PO will be administered as per the schedule specified in the respective arm.
    name
    Prednisone
    type
    DRUG
  8. arm Group Labels
    1. R-CHOP plus Polatuzumab Vedotin Placebo
    description
    Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.
    name
    Polatuzumab vedotin Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
1000
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
    time Frame
    From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)
secondary Outcomes
  1. measure
    Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)
    time Frame
    End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
  2. measure
    Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
    time Frame
    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)
  3. measure
    Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
    time Frame
    24 months after enrollment (up to approximately 65 months)
  4. measure
    Overall Survival
    time Frame
    From randomization until death from any cause (up to approximately 65 months)
  5. measure
    Percentage of Participants With CR as Assessed by FDG-PET by Investigator
    time Frame
    End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
  6. measure
    Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
    time Frame
    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)
  7. measure
    Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
    time Frame
    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)
  8. measure
    Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
    time Frame
    From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
  9. measure
    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
    time Frame
    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)
  10. measure
    Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
    time Frame
    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)
  11. measure
    Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue
    time Frame
    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)
  12. measure
    Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS
    time Frame
    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)
Full study description
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).
Source references
references
  1. citation
    Morschhauser F, Lenz G, Herrera AF, Flowers CR, Trneny M, Burke JM, Hou JZ, Staber PB, Hawkes EA, Izutsu K, Le Gouill S, Belada D, Tucci A, Yan M, Harris W, Lu K, Bolen CR, Hirata J, Lee C, Jiang Y, Jardin F, Hatzi K. Low lymphoma macrophage infiltration predicts poor outcomes for R-CHOP- but not Pola-R-CHP-treated patients with DLBCL. Blood Neoplasia. 2026 Jul 2;3(4):100264. doi: 10.1016/j.bneo.2026.100264. eCollection 2026 Nov.
    pmid
    42699559
    type
    DERIVED
  2. citation
    Thompson C, Trneny M, Morschhauser F, Salles G, Reagan PM, Hertzberg M, Zhang H, Thieblemont C, Hu B, Fonseca G, Kim WS, Martelli M, Mehta A, Singh A, Yan M, Hirata J, Sugidono M, Lee C, Sharman JP, Mehta-Shah N, Flowers CR, Tilly H, Chua N, Casasnovas RO, Miall F, Kim TM, Tsai XC, Nasta S, Lee ST, Friedberg JW. PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study. Blood. 2026 Jan 15;147(3):254-265. doi: 10.1182/blood.2025028848.
    pmid
    40997297
    type
    DERIVED
  3. citation
    Morschhauser F, Salles G, Sehn LH, Herrera AF, Friedberg JW, Trneny M, Lenz G, Sharman JP, Herbaux C, Burke JM, Matasar M, Collins GP, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Pinto A, Rai S, Izutsu K, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Jiang Y, McCall B, Chohan S, Sugidono M, Yan M, Batlevi CL, Tilly H, Flowers CR. Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec 10;43(35):3698-3705. doi: 10.1200/JCO-25-00925. Epub 2025 Sep 24.
    pmid
    40991874
    type
    DERIVED
  4. citation
    Hu B, Reagan PM, Sehn LH, Sharman JP, Hertzberg M, Zhang H, Kim A, Herbaux C, Molina L, Maruyama D, Stenner F, Chohan S, Kothari R, Lee Batlevi C, Hirata J, Sahin D, Lee C, Sugidono M, Tilly H. Subgroup analysis of older patients >/=60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study. Blood Adv. 2025 May 27;9(10):2489-2499. doi: 10.1182/bloodadvances.2024014707.
    pmid
    40085955
    type
    DERIVED
  5. citation
    Liao MZ, Deng R, Gibiansky L, Lu T, Agarwal P, Dere R, Lee C, Hirata J, Herbaux C, Salles G, Li C, Miles D. Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non-Asian patients with previously untreated diffuse large B-cell lymphoma in POLARIX. Clin Transl Sci. 2023 Dec;16(12):2744-2755. doi: 10.1111/cts.13669. Epub 2023 Oct 31.
    pmid
    37864313
    type
    DERIVED
  6. citation
    Song Y, Tilly H, Rai S, Zhang H, Jin J, Goto H, Terui Y, Shin HJ, Kim WS, Cao J, Feng J, Eom HS, Kim TM, Tsai XC, Gau JP, Koh H, Zhang L, Song Y, Yang Y, Li W, Huang H, Ando K, Sharman JP, Sehn LH, Bu L, Wang X, Jiang Y, Hirata J, Lee C, Zhu J, Izutsu K. Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial. Blood. 2023 Apr 20;141(16):1971-1981. doi: 10.1182/blood.2022017734.
    pmid
    36626583
    type
    DERIVED
  7. citation
    Varma G, Wang J, Diefenbach C. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. Expert Rev Anticancer Ther. 2022 Aug;22(8):795-803. doi: 10.1080/14737140.2022.2093191. Epub 2022 Jun 27.
    pmid
    35726803
    type
    DERIVED
  8. citation
    Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trneny M, Sharman JP, Herbaux C, Burke JM, Matasar M, Rai S, Izutsu K, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Pinto A, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Hirata J, Jiang Y, Yan M, Lee C, Flowers CR, Salles G. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. Epub 2021 Dec 14.
    pmid
    34904799
    type
    DERIVED
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        14 CLINICAL STUDIES 14.1 Previously Untreated DLBCL, NOS or HGBL GO39942 (POLARIX) The efficacy of POLIVY was evaluated in POLARIX (NCT03274492), a randomized double-blind, placebo-controlled, multicenter trial in patients with previously untreated large B-cell lymphoma. Eligible patients were aged 18–
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    Preserved source evidence · Independent clinical review pending · Not medical advice