Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

October 11, 2010

Primary Completion Date

December 19, 2016

Study Completion Date

December 19, 2016

Conditions
Non-Hodgkin's Lymphoma
Interventions
BIOLOGICAL

Ofatumumab

liquid concentrate for solution for infusion in glass vials containing 50 mL of solution at a concentration of 20mg/ml to provide 1000 mg per vial.

BIOLOGICAL

Rituximab

sourced locally from commercial stock

BIOLOGICAL

Ofatumumab

Four weekly doses of single agent ofatumumab (1000 mg), followed by ofatumumab (1000 mg) every two months for four additional doses.

BIOLOGICAL

Rituximab

Four weekly doses of single agent rituximab (375 mg/m2), followed by rituximab (375 mg/m2) every two months for four additional doses.

Trial Locations (155)

1000

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Brussels

1122

Novartis Investigative Site, Budapest

1233

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

2020

Novartis Investigative Site, Antwerp

2060

Novartis Investigative Site, Antwerp

2193

Novartis Investigative Site, Parktown

2196

Novartis Investigative Site, Saxonwold, Johannesburg

2610

Novartis Investigative Site, Wilrijk

3000

Novartis Investigative Site, Leuven

4000

Novartis Investigative Site, Plovdiv

4012

Novartis Investigative Site, Debrecen

4126

Novartis Investigative Site, Athlone Park, Amanzimtoti

5800

Novartis Investigative Site, Pleven

6045

Novartis Investigative Site, Port Elizabeth

6720

Novartis Investigative Site, Szeged

8000

Novartis Investigative Site, Bruges

8500

Novartis Investigative Site, Kortrijk

9010

Novartis Investigative Site, Varna

9023

Novartis Investigative Site, Győr

10042

Novartis Investigative Site, Lake Success

10549

Novartis Investigative Site, Mount Kisco

17522

Novartis Investigative Site, Ephrata

17605

Novartis Investigative Site, Lancaster

17822

Novartis Investigative Site, Danville

19090

Novartis Investigative Site, Willow Grove

20910

Novartis Investigative Site, Silver Spring

22408

Novartis Investigative Site, Fredericksburg

27403

Novartis Investigative Site, Greensboro

30060

Novartis Investigative Site, Marietta

32806

Novartis Investigative Site, Orlando

33028

Novartis Investigative Site, Pembroke Pines

33401

Novartis Investigative Site, West Palm Beach

33604

Novartis Investigative Site, Pessac

33805

Novartis Investigative Site, Lakeland

34295

Novartis Investigative Site, Montpellier

34952

Novartis Investigative Site, Port Saint Lucie

37404

Novartis Investigative Site, Chattanooga

37916

Novartis Investigative Site, Knoxville

38138

Novartis Investigative Site, Germantown

39202

Novartis Investigative Site, Jackson

40353

Novartis Investigative Site, Mount Sterling

44708

Novartis Investigative Site, Canton

44710

Novartis Investigative Site, Canton

46016

Novartis Investigative Site, Anderson

46237

Novartis Investigative Site, Indianapolis

49007

Novartis Investigative Site, Kalamazoo

49503

Novartis Investigative Site, Grand Rapids

50010

Novartis Investigative Site, Ames

58501

Novartis Investigative Site, Bismarck

59715

Novartis Investigative Site, Bozeman

60076

Novartis Investigative Site, Skokie

60201

Novartis Investigative Site, Evanston

61615

Novartis Investigative Site, Peoria

62301

Novartis Investigative Site, Quincy

62321

Novartis Investigative Site, Boulogne-sur-Mer

63003

Novartis Investigative Site, Clermont-Ferrand

64111

Novartis Investigative Site, Kansas City

64507

Novartis Investigative Site, Saint Joseph

65201

Novartis Investigative Site, Columbia

65807

Novartis Investigative Site, Springfield

68506

Novartis Investigative Site, Lincoln

68510

Novartis Investigative Site, Lincoln

70006

Novartis Investigative Site, Metairie

71103

Novartis Investigative Site, Shreveport

71913

Novartis Investigative Site, Hot Springs

72015

Novartis Investigative Site, Le Mans

77030

Novartis Investigative Site, Houston

78234

Novartis Investigative Site, Fort Sam Houston

79044

Novartis Investigative Site, Lviv

83045

Novartis Investigative Site, Donetsk

84106

Novartis Investigative Site, Salt Lake City

84403

Novartis Investigative Site, Ogden

85234

Novartis Investigative Site, Gilbert

85925

Novartis Investigative Site, La Roche-sur-Yon

86132

Novartis Investigative Site, Makiivka

87110

Novartis Investigative Site, Albuquerque

87131

Novartis Investigative Site, Albuquerque

90403

Novartis Investigative Site, Santa Monica

92123

Novartis Investigative Site, San Diego

92270

Novartis Investigative Site, Rancho Mirage

93901

Novartis Investigative Site, Salinas

93940

Novartis Investigative Site, Monterey

94523

Novartis Investigative Site, Pleasant Hill

94806

Novartis Investigative Site, San Pablo

94904

Novartis Investigative Site, Greenbrae

95023

Novartis Investigative Site, Simferopil

97213

Novartis Investigative Site, Portland

98034

Novartis Investigative Site, Kirkland

98109

Novartis Investigative Site, Seattle

98112

Novartis Investigative Site, Seattle

98273

Novartis Investigative Site, Mount Vernon

98382

Novartis Investigative Site, Sequim

99208

Novartis Investigative Site, Spokane

99336

Novartis Investigative Site, Kennewick

99508

Novartis Investigative Site, Anchorage

100021

Novartis Investigative Site, Beijing

100044

Novartis Investigative Site, Beijing

100071

Novartis Investigative Site, Beijing

100142

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

300020

Novartis Investigative Site, Tianjin

310003

Novartis Investigative Site, Hangzhou

510060

Novartis Investigative Site, Guangzhou

510080

Novartis Investigative Site, Guangzhou

06776

Novartis Investigative Site, New Milford

06790

Novartis Investigative Site, Torrington

31201-8300

Novartis Investigative Site, Macon

04901

Novartis Investigative Site, Waterville

41253-190

Novartis Investigative Site, Salvador

32.651-760

Novartis Investigative Site, Betim

80060-900

Novartis Investigative Site, Curitiba

90470-340

Novartis Investigative Site, Porto Alegre

14784-400

Novartis Investigative Site, Barretos

17210-080

Novartis Investigative Site, Jaú

01223-001

Novartis Investigative Site, São Paulo

01308-000

Novartis Investigative Site, São Paulo

04039-901

Novartis Investigative Site, São Paulo

05403-000

Novartis Investigative Site, São Paulo

20230 -130

Novartis Investigative Site, Rio de Janeiro

22793-080

Novartis Investigative Site, Rio de Janeiro

Unknown

Novartis Investigative Site, Sofia

Novartis Investigative Site, Hradec Králové

E1C 6Z8

Novartis Investigative Site, Moncton

N2G 1G3

Novartis Investigative Site, Kitchener

G1J 1Z4

Novartis Investigative Site, Québec

J1H 5N4

Novartis Investigative Site, Sherbrooke

625 00

Novartis Investigative Site, Brno

708 52

Novartis Investigative Site, Ostrava

128 08

Novartis Investigative Site, Prague

466-8650

Novartis Investigative Site, Aichi

602-8566

Novartis Investigative Site, Kyoto

980-8574

Novartis Investigative Site, Miyagi

852-8501

Novartis Investigative Site, Nagasaki

350-8550

Novartis Investigative Site, Saitama

329-0498

Novartis Investigative Site, Tochigi

104-0045

Novartis Investigative Site, Tokyo

135-8550

Novartis Investigative Site, Tokyo

Lima 18

Novartis Investigative Site, Miraflores

Lima 27

Novartis Investigative Site, San Isidro

Lima 11

Novartis Investigative Site, Lima

Lima 34

Novartis Investigative Site, Lima

Lima 41

Novartis Investigative Site, Lima

00918

Novartis Investigative Site, San Juan

833 10

Novartis Investigative Site, Bratislava

041 66

Novartis Investigative Site, Košice

036 59

Novartis Investigative Site, Martin

602-715

Novartis Investigative Site, Busan

120-752

Novartis Investigative Site, Seoul

135-710

Novartis Investigative Site, Seoul

03022

Novartis Investigative Site, Kyiv

03115

Novartis Investigative Site, Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Novartis Pharmaceuticals

INDUSTRY