POLARIX: 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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03274492
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 243
• Arms: 2
• Anticipated Duration (Months): 103
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma	Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Vincristine Placebo; Drug: Prednisone; Drug: Polatuzumab vedotin Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 16, 2017
• Anticipated Primary Completion Date: Jun 18, 2026
• Anticipated Study Completion Date: Jun 18, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Polatuzumab Vedotin; Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.; Other Names: DCDS4501A; anti-CD79b-VC-MMAE ; Drug: Rituximab; Rituximab IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Cyclophosphamide; Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Doxorubicin; Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Vincristine Placebo; Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.; Drug: Prednisone; Prednisone PO will be administered as per the schedule specified in the respective arm.
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.	Drug: Rituximab; Rituximab IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Cyclophosphamide; Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Doxorubicin; Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Vincristine; Vincristine IV infusion will be administered as per the schedule specified in the respective arm.; Drug: Prednisone; Prednisone PO will be administered as per the schedule specified in the respective arm.; Drug: Polatuzumab vedotin Placebo; Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [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 Measures

1. Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR) [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. Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [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. Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [24 months after enrollment (up to approximately 65 months)]

4. Overall Survival [From randomization until death from any cause (up to approximately 65 months)]

5. Percentage of Participants With CR as Assessed by FDG-PET by Investigator [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. Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [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. Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [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. Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma [From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)]

9. 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 [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. Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS) [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. Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue [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. Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS [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)]

13. EORTC QLQ-C30 Treatment-Related Symptoms Score [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)]

14. Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score [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)]

15. Percentage of Participants With adverse Events (AEs) [From randomization to the end of study (up to approximately 65 months)]

16. Serum Concentration of Total Polatuzumab Vedotin [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)]

17. Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE]) [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)]

18. Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE [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)]

19. Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin [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 Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Southern Cancer Center	Daphne	Alabama	United States	36526
3	City of Hope	Duarte	California	United States	91010
4	Ronald Reagan UCLA Medical Center; Drug Information Center	Los Angeles	California	United States	90095
5	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
6	Florida Cancer Specialists - Fort Myers (New Hampshire Ct)	Fort Myers	Florida	United States	33901-8101
7	Florida Cancer Specialists & Research Institute	Saint Petersburg	Florida	United States	33705
8	Florida Cancer Specialists	West Palm Beach	Florida	United States	33401
9	Emory University; Investigational Drug Service	Atlanta	Georgia	United States	30322
10	Illinois Cancer Specialists	Arlington Heights	Illinois	United States	60005
11	University of Louisville Hospital; The James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202
12	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
13	University of Maryland	Baltimore	Maryland	United States	21201
14	Johns Hopkins University	Baltimore	Maryland	United States	21287
15	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
16	Dana Farber Cancer Institute; Lymphoma Program	Boston	Massachusetts	United States	02115
17	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
18	University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology	Ann Arbor	Michigan	United States	48109
19	Karmanos Cancer Center	Detroit	Michigan	United States	48201
20	HCA Midwest Division	Kansas City	Missouri	United States	64132
21	Washington University; Wash Uni. Sch. Of Med	Saint Louis	Missouri	United States	63110
22	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
23	Roswell Park Cancer Institute; Grace Cancer Drug Center	Buffalo	New York	United States	14263
24	Memorial Sloan Kettering Cancer Center - Commack	Commack	New York	United States	11725
25	Memorial Sloan Kettering Cancer Center at Westchester	Harrison	New York	United States	10604
26	New York University Cancer Cen	New York	New York	United States	10016
27	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
28	University of Rochester Medical Center	Rochester	New York	United States	14618
29	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27514
30	Levine Cancer Institute - Clincal Trials Administration	Charlotte	North Carolina	United States	28204
31	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
32	Ohio State University; B406 Starling-Loving Hall	Columbus	Ohio	United States	43210
33	Oncology/Hematology Care Clinical Trials LLC	Fairfield	Ohio	United States	45014
34	Oncology Associates of Oregon, P.C	Eugene	Oregon	United States	97401
35	Oregon HSU; Bld-Brain Barr/Neuro-Onc	Portland	Oregon	United States	97239
36	Northwest Cancer Specialists - Portland (SW Barnes Rd)	Tigard	Oregon	United States	97223
37	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
38	Fox Chase Cancer Center; Hematology/Oncology	Philadelphia	Pennsylvania	United States	19111
39	University of Pittsburgh Medical Center Cancer Center; Pharmacy	Pittsburgh	Pennsylvania	United States	15232
40	Medical University of South Carolina Hospital	Charleston	South Carolina	United States	29425
41	Prisma Health - Upstate	Greenville	South Carolina	United States	29615
42	Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street	Chattanooga	Tennessee	United States	37404
43	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
44	Texas Oncology-Austin Midtown	Austin	Texas	United States	78705
45	Rocky Mountain Cancer Centers, LLP	Irving	Texas	United States	75063
46	Texas Oncology-Tyler	Irving	Texas	United States	75063
47	Texas Oncology San Antonio Medical Center	San Antonio	Texas	United States	78240
48	University of Utah; Huntsman Cancer Hospital	Salt Lake City	Utah	United States	84112
49	Oncology Associates of Southwest Virginia, Inc.	Blacksburg	Virginia	United States	24060
50	Virginia Cancer Specialists, PC	Fairfax	Virginia	United States	22031
51	Shenandoah Oncology Associates	Winchester	Virginia	United States	22601
52	Seattle Cancer Care Alliance; Investigational Drug Service	Seattle	Washington	United States	98101
53	North Star Lodge	Yakima	Washington	United States	98902
54	West Virginia Uni Med. Center - Robert Byrd Health Science	Morgantown	West Virginia	United States	26506
55	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
56	St George Hospital	Kogarah	New South Wales	Australia	2217
57	Prince of Wales Hospital; Haematology	Randwick	New South Wales	Australia	2031
58	Calvary Mater Newcastle	Waratah	New South Wales	Australia	2298
59	Westmead Hospital; Outpatient Pharmacy University Clinic	Westmead	New South Wales	Australia	2145
60	Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology	Woolloongabba	Queensland	Australia	4102
61	Ashford Cancer Center Research	Kurralta Park	South Australia	Australia	5037
62	The University of Adelaide - The Queen Elizabeth Hospital (TQEH)	Woodville South	South Australia	Australia	5011
63	Monash Medical Centre	Clayton	Victoria	Australia	3168
64	Austin Hospital; Cancer Clinical Trials Centre	Melbourne	Victoria	Australia	3084
65	Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III	Innsbruck		Austria	6020
66	Landesklinikum Krems	Krems		Austria	3500
67	Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)	Salzburg		Austria	5020
68	Medizinische Universität Wien	Wien		Austria	1090
69	Wiener Gesundheitsverbund - Klinik Ottakring	Wien		Austria	1160
70	UZ Gent	Gent		Belgium	9000
71	CH Jolimont - Lobbes (Jolimont)	Haine-Saint-Paul		Belgium	7100
72	CHU UCL Mont-Godinne	Mont-godinne		Belgium	5530
73	Hospital Erasto Gaertner	Curitiba	PR	Brazil	81520-060
74	Hospital Sao Vicente de Paulo	Passo Fundo	RS	Brazil	99010-090
75	Hospital das Clinicas - UFRGS	Porto Alegre	RS	Brazil	90035-903
76	Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP	Campinas	SP	Brazil	13083-878
77	Hospital das Clinicas - FMUSP	Sao Paulo	SP	Brazil	05403-900
78	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 1Z2
79	BC Cancer - Vancouver	Vancouver	British Columbia	Canada	V5Z 4E6
80	CancerCare Manitoba (CCMB)	Winnipeg	Manitoba	Canada	MB R3E 0V9
81	McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences	Hamilton	Ontario	Canada	L8V 5C2
82	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
83	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
84	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario	Canada	M5G 2M9
85	CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
86	Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)	Montreal	Quebec	Canada	H2X 1P1
87	CHU de Quebec-Universite Laval	Quebec		Canada	G1S 4L8
88	Peking Union Medical College Hospital	Beijing City		China	100032
89	Beijing Cancer Hospital	Beijing		China	100142
90	The First Hospital of Jilin University	Changchun City		China	130021
91	Fujian Provincial Cancer Hospital	Fuzhou City		China	350014
92	Sun Yet-sen University Cancer Center	Guangzhou		China	510060
93	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou		China	310003
94	Jiangsu Cancer Hospital	Nanjing City		China	211100
95	Jiangsu Province Hospital	Nanjing		China	210036
96	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai City		China	200025
97	Shanghai East Hospital, Tongji University	Shanghai City		China	200032
98	Fudan University Shanghai Cancer Center	Shanghai City		China	200120
99	Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences	Tianjin City		China	300020
100	Tianjin Medical University Cancer Institute & Hospital	Tianjing		China	300060
101	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City		China	430023
102	Henan Cancer Hospital	Zhengzhou		China	450008
103	Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika	Hradec Kralove		Czechia	500 05
104	Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika	Hradec Kralove		Czechia	500 05
105	Fakultni nemocnice Olomouc	Olomouc		Czechia	775 20
106	Fakultni nemocnice Ostrava	Ostrava - Poruba		Czechia	708 52
107	Univerzita Karlova v Praze 1. Lekarska Fakulta	Prague		Czechia	128 08
108	CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire	Amiens		France	80054
109	CHU Angers	Angers		France	49933
110	Centre Hospitalier de La Cote Basque; Hematologie	Bayonne		France	64109
111	Hopital Jean Minjoz; Hematologie	Besancon		France	25030
112	Institut Bergonie	Bordeaux		France	33076
113	Institut d'Hématologie de Basse Normandie	Caen		France	14000
114	CH Metropole de Savoie	CHAMBERY Cedex		France	73011
115	Hopital Henri Mondor; Hematologie Clinique	Creteil		France	94010
116	CHU de Dijon - Hopital le Bocage	Dijon		France	21000
117	L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard	Grenoble		France	38000
118	CHD Vendée	La Roche Sur Yon		France	85025
119	Hôpital Albert Michallon; Hematologie Clinique	La Tronche		France	38700
120	Clinique Victor Hugo - Centre Jean Bernard	Le Mans Cedex 02		France	72015
121	Hôpital Saint Vincent de Paul	Lille		France	59000
122	Hopital Claude Huriez; Hematologie	Lille		France	59037
123	Hopital Uni Ire Dupuytren; Hematologie	Limoges		France	87042
124	Centre Leon Berard	Lyon		France	69008
125	CHU Montpellier - Saint ELOI	Montpellier		France	34295
126	CHU de Nantes - Hotel Dieu	Nantes		France	44093
127	Centre Antoine Lacassagne	Nice		France	06189
128	CHU de Nîmes - Hôpital Carémeau	Nimes		France	30029
129	Hôpital Saint-Louis; Service d'Hématologie	Paris		France	75475
130	Gh Necker Enfants Malades; Hematologie Clinique	Paris		France	75743
131	Hopital Saint Jean; Hematologie	Perpignan		France	66046
132	Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique	Pessac		France	33604
133	CHU Lyon Sud - Service Hématologie	Pierre Benite		France	69310
134	CHU de Poitiers	Poitiers		France	86021
135	Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang	Quimper Cedex		France	29107
136	Hopital Pontchaillou; Hematologie Clinique	Rennes		France	35033
137	Centre Henri Becquerel; Hematologie	Rouen		France	76038
138	Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll	St Brieuc		France	22027
139	Pôle de Cancérologie - CHU de Saint-Etienne'	St Priest en Jarez		France	42270
140	CHRU DE STRASBOURG; Département d'Hématologie et Oncologie	Strasbourg		France	67091
141	Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)	Toulouse		France	31059
142	CHU Bretonneau	Tours		France	37044
143	CHU de Brabois	Vandoeuvre Les Nancy		France	54511
144	CH Bretagne Atlantique; Médecine interne	Vannes Cedex		France	56017
145	Institut Gustave Roussy; Unite D'Hematologie	Villejuif		France	94805
146	Vivantes Klinikum Am Urban	Berlin		Germany	10967
147	Städtisches Klinikum Dessau	Dessau-Roßlau		Germany	06847
148	Universitätsklinikum Essen	Essen		Germany	45147
149	Universitaetsklinikum Halle (Saale)	Halle		Germany	06120
150	Universitaetsklinikum Heidelberg	Heidelberg		Germany	69120
151	InVO - Institut für Versorgungsforschung in der Onkologie GbR	Koblenz		Germany	56068
152	University of Munich	München		Germany	81675
153	Universitatsklinikum Munster	Münster		Germany	48149
154	Queen Mary Hospital	Hong Kong		Hong Kong
155	Queen Elizabeth Hospital	Kowloon		Hong Kong
156	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	Abruzzo	Italy	24060
157	Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia	Brescia	Abruzzo	Italy
158	Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica	Rome	Abruzzo	Italy
159	Azienda Ospedaliera Universitaria Senese	Siena	Abruzzo	Italy	53100
160	AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova	Reggio Emilia	Emilia-Romagna	Italy	42100
161	IRCCS AOU San Martino - IST	Genova	Liguria	Italy	16132
162	Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia	Milano	Lombardia	Italy	20133
163	Istituto Nazionale dei Tumori	Monza	Lombardia	Italy	20052
164	Azienda Ospedaliero Universitaria Maggiore della Carita di Novara	Novara	Piemonte	Italy	28100
165	Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette	Torino	Piemonte	Italy	10026
166	Aichi Cancer Center	Aichi		Japan	464-8681
167	Chiba University Hospital	Chiba		Japan	260-8677
168	Chiba Cancer Center	Chiba		Japan	260-8717
169	National Cancer Center Hospital East	Chiba		Japan	277-8577
170	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
171	Kyushu University Hospital	Fukuoka		Japan	812-8582
172	Hiroshima University Hospital	Hiroshima		Japan	734-8551
173	Hokkaido University Hospital	Hokkaido		Japan	060-8648
174	Kobe City Medical Center General Hospital	Hyogo		Japan	650-0047
175	Tokai University Hospital	Kanagawa		Japan	259-1193
176	Kumamoto University Hospital	Kumamoto		Japan	860-8556
177	University Hospital Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
178	Tohoku University Hospital	Miyagi		Japan	980-8574
179	Osaka Metropolitan University Hospital	Osaka		Japan	545-8586
180	Osaka University Hospital	Osaka		Japan	565-0871
181	Kindai University Hospital	Osaka		Japan	589-8511
182	Jichi Medical University Hospital	Tochigi		Japan	329-0498
183	National Cancer Center Hospital	Tokyo		Japan	104-0045
184	The Cancer Institute Hospital of JFCR	Tokyo		Japan	135-8550
185	Inje University Busan Paik Hospital	Busan		Korea, Republic of	47392
186	Pusan National University Hospital	Busan		Korea, Republic of	49241
187	National Cancer Center; Medical Oncology	Gyeonggi-do		Korea, Republic of	410-769
188	Seoul National University Hospital	Seoul		Korea, Republic of	03080
189	Severance Hospital	Seoul		Korea, Republic of	03722
190	Asan Medical Center	Seoul		Korea, Republic of	05505
191	Samsung Medical Center	Seoul		Korea, Republic of	06351
192	Pusan National University Yangsan Hospital; hemato-oncology	Yangsan		Korea, Republic of
193	Auckland City Hospital, Cancer and Blood Research	Auckland		New Zealand	1023
194	Canterbury Health Laboratories; Immunology/Rheumatology	Christchurch		New Zealand	8140
195	Waikato Hospital	Hamilton		New Zealand	3248
196	Palmerston North Hospital	Palmerston North		New Zealand	4410
197	Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich w Chorzowie	Chorzów		Poland	41-500
198	Malopolskie Centrum Medyczne	Krakow		Poland	30-510
199	SPZOZ Ministerstwa Spraw Wewnętrznych i Administracji w Poznaniu; Oddział Hematologii	Poznań		Poland	60-631
200	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie	Warszawa		Poland	02-781
201	Wojskowy Instytut Medyczny	Warszawa		Poland	04-141
202	Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w Łodzi	Łódź		Poland	93-510
203	Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic	Kazan	Tatarstan	Russian Federation	420029
204	Penza Regional Oncology Dispensary	Penza		Russian Federation	440071
205	Leningrad Regional Clinical Hospital	St Petersburg		Russian Federation	194291
206	Institut Catala d Oncologia Hospitalet	Hospitalet de Llobregat	Barcelona	Spain	08908
207	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid	Spain	28220
208	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008
209	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
210	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
211	Hospital Clinic Barcelona	Barcelona		Spain	08036
212	Hospital San Pedro de Alcantara	Caceres		Spain	10003
213	Hospital Universitari Dr. Josep Trueta	Girona		Spain	17007
214	Hospital Universitario La Paz	Madrid		Spain	280146
215	Hospital Quiron Madrid	Madrid		Spain	28033
216	Fundación Jimenez Díaz	Madrid		Spain	28040
217	Hospital Universitario Virgen de la Victoria	Malaga		Spain	29010
218	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
219	Hirslanden Medical Center, Tumorzentrum	Aarau		Switzerland	5000
220	Universitätsspital Basel Gynäkologie - Onkologie	Basel		Switzerland	4031
221	Hopital Cantonal Universitaire De Geneve	Genève		Switzerland	1211
222	Kaohsiung Medical University Hospital, Cancer Center	Kaohsiung		Taiwan	807
223	China Medical University Hospital; Clinical Research Center Clinical Pharmacy	Taichung		Taiwan	40447
224	Chi-Mei Hospital, Liouying	Tainan		Taiwan	736
225	Taipei Veterans General Hospital	Taipei City		Taiwan	11217
226	National Taiwan University Hospital	Taipei		Taiwan	10002
227	Ankara University Faculty of Medicine Cebeci Hospital	Ankara		Turkey	06700
228	Ege Üniversitesi Tip Fakültesi	Lzmir		Turkey	35100
229	Dokuz Eylul Universitesi Tip Fakultesi	Lzmir		Turkey	35340
230	Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi	Teşvi̇ki̇ye		Turkey	34365
231	Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council	Cherkassy	Chernihiv Governorate	Ukraine
232	MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care	Lviv	Chernihiv Governorate	Ukraine	79007
233	Khmelnytskyi Regional Hospital; Department of Hemathology	Khmelnytskyi	Kharkiv Governorate	Ukraine	29000
234	Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis	Kyiv	Volhynian Governorate	Ukraine	03143
235	Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital	Cambridge		United Kingdom	CB2 0QQ
236	East Kent Hospitals University NHS Foundation Trust	Canterbury		United Kingdom	CT1 3NG
237	University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary	Leicester		United Kingdom	LE1 5WW
238	Barts Health NHS Trust; Bartholomew's H., King George V Building	London		United Kingdom	EC1A 7BE
239	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX
240	The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital	Newcastle upon Tyne		United Kingdom	NE7 7DN
241	Nottingham City Hospital; Dept of Haematology	Nottingham		United Kingdom	NG5 1PB
242	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom	OX3 7LE
243	University Hospital Southampton NHS Foundation Trust	Southhampton		United Kingdom	SO16 6YD

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03274492
• Other Study ID Numbers: GO39942; 2017-002023-21
• First Posted: Sep 7, 2017
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Antibodies, Monoclonal; Immunoconjugates

Study Results

No Results Posted as of May 31, 2022