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
- Diffuse Large B-Cell Lymphoma
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Aarau
- Amiens
- Angers
- Ankara
- Ann Arbor
- Arlington Heights
- Atlanta
- Auckland
- Austin
- Baltimore
- Barcelona
- Basel
- Bayonne
- bei-jing-shi
- Bergamo
- Berlin
- Besançon
- Birmingham
- Blacksburg
- Bordeaux
- Boston
- Brescia
- Buffalo
- Busan
- Caen
- Cambridge
- Canterbury
- Chambéry
- chang-chun-shi
- Chapel Hill
- Charleston
- Charlotte
- Chattanooga
- Cherkasy
- Chiba
- Chorzów
- Christchurch
- Chuo City
- Clayton
- Cleveland
- Columbus
- Commack
- Concord
- Créteil
- Cáceres
- Daphne
- Dessau-Roßlau
- Detroit
- Dijon
- Duarte
- Edmonton
- Essen
- Eugene
- Fairfax
- Fairfield
- Fort Myers
- fu-zhou-shi
- Fukuoka
- Genova
- Gent
- Genève
- Girona
- glandore
- Goyang-si
- Greenville
- Grenoble
- guang-zhou-shi
- Halle (Saale)
- Hamilton
- hang-zhou-shi
- Harrison
- Heidelberg
- Hiroshima
- Hlavní město Praha
- Hong Kong Island
- Hradec Králové
- Innsbruck
- Irving
- Isehara
- İstanbul
- İzmir
- Kansas City
- Kaohsiung City
- Kashiwa
- Kazan
- khmel-nyts-kyi
- Kobe
- Koblenz
- Kogarah
- Koto City
- Kraków
- Krems an der Donau
- Kumamoto
- Kyiv
- Kyoto
- L'Hospitalet de Llobregat
- L'viv
- La Louvière
- La Roche-sur-Yon
- La Tronche
- Le Mans
- Leicester
- Lille
- Limoges
- London
- Los Angeles
- Louisville
- Lviv
- Lyon
- Madrid
- Majadahonda
- Manchester
- Milano
- Montpellier
- Montréal
- Montvale
- Morgantown
- Málaga
- München
- Münster
- Nagoya
- nan-jing-shi
- Nantes
- Nashville
- New Orleans
- New York
- Newcastle upon Tyne
- Nice
- Nottingham
- Novara
- Nîmes
- Olomouc
- Osaka
- Osakasayama
- Ostrava
- Ottawa
- Oxford
- Palmerston North
- Pamplona
- Paraná
- Paris
- Penza
- Perpignan
- Pessac
- Philadelphia
- Pierre-Bénite
- Pittsburgh
- Poitiers
- Portland
- Poznań
- Quimper
- Québec
- Randwick
- Reggio Emilia
- Rennes
- Rio Grande do Sul
- Rochester
- Roma
- Rouen
- Saint-Brieuc
- Saint-Priest-en-Jarez
- Salt Lake City
- Salzburg
- San Antonio
- Sankt-Peterburg
- Sapporo
- Seattle
- Sendai
- Seoul
- Sevilla
- shang-hai-shi
- Shimotsuke
- Siena
- Southampton
- St. Louis
- St. Petersburg
- Strasbourg
- Suita
- São Paulo
- Taichung City
- Tainan City
- Taipei City
- tian-jin-shi
- Torino
- Toronto
- Toulouse
- Tours
- Tyler
- Vancouver
- Vandœuvre-lès-Nancy
- Vannes
- Villejuif
- Waratah
- Warszawa
- Washington
- West Palm Beach
- Westmead
- Wien
- Winchester
- Winnipeg
- Woodville South
- Woolloongabba
- wu-han-shi
- Yakima
- Yangsan
- Yvoir
- zheng-zhou-shi
- Łódź
Trial Identifier:
NCT03274492 2017-002023-21 GO39942
Trial 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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03274492 , GO39942 , 2017-002023-21
Trial Identifier
Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Vincristine Placebo, Prednisone, Polatuzumab vedotin Placebo
Treatments
Diffuse Large B-Cell Lymphoma
Condition
Official 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
Eligibility Criteria
All
Gender
≥ 18 Years & ≤ 80 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com