Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

447

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

February 28, 2014

Study Completion Date

November 30, 2014

Conditions
Lymphoma, Large-Cell, Diffuse
Interventions
DRUG

OFATUMUMAB + DHAP

3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.

DRUG

RITUXIMAB + DHAP

3 cycles of treatment will be administered. Each cycle will last 21 days. rituximab dose: cycle 1, day 1 - 375 mg/m2; cycle 1, day 8 - 375 mg/m2; cycle 2, day 1 and cycle 3, day 1 - 375 mg/m2. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle.

Trial Locations (173)

4

GSK Investigational Site, Dublin

8

GSK Investigational Site, James Street

1090

GSK Investigational Site, Vienna

1097

GSK Investigational Site, Budapest

1122

GSK Investigational Site, Budapest

1140

GSK Investigational Site, Vienna

1200

GSK Investigational Site, Brussels

2100

GSK Investigational Site, Copenhagen

3000

GSK Investigational Site, Leuven

3500

GSK Investigational Site, Hasselt

4012

GSK Investigational Site, Debrecen

4020

GSK Investigational Site, Linz

4021

GSK Investigational Site, Linz

5530

GSK Investigational Site, Yvoir

6020

GSK Investigational Site, Innsbruck

6720

GSK Investigational Site, Szeged

7400

GSK Investigational Site, Kaposvár

8000

GSK Investigational Site, Bruges

8036

GSK Investigational Site, Graz

9000

GSK Investigational Site, Ghent

9023

GSK Investigational Site, Győr

9700

GSK Investigational Site, Szombathely

10065

GSK Investigational Site, New York

10330

GSK Investigational Site, Bangkok

10400

GSK Investigational Site, Bangkok

10700

GSK Investigational Site, Bangkok

11525

GSK Investigational Site, Athens

13210

GSK Investigational Site, Syracuse

13353

GSK Investigational Site, Berlin

13419

GSK Investigational Site, Tallinn

19140

GSK Investigational Site, Philadelphia

28006

GSK Investigational Site, Madrid

28007

GSK Investigational Site, Madrid

28008

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Majadahonda (Madrid)

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

29425

GSK Investigational Site, Charleston

29601

GSK Investigational Site, Greenville

30120

GSK Investigational Site, Murcia

31008

GSK Investigational Site, Pamplona

33520

GSK Investigational Site, Tampere

37007

GSK Investigational Site, Salamanca

37203

GSK Investigational Site, Nashville

48149

GSK Investigational Site, Münster

49100

GSK Investigational Site, Petah Tikva

51014

GSK Investigational Site, Tartu

52074

GSK Investigational Site, Aachen

52621

GSK Investigational Site, Ramat Gan

60637

GSK Investigational Site, Chicago

66205

GSK Investigational Site, Westwood

78229

GSK Investigational Site, San Antonio

89081

GSK Investigational Site, Ulm

90029

GSK Investigational Site, Oulu

95816

GSK Investigational Site, Sacramento

98108

GSK Investigational Site, Seattle

100021

GSK Investigational Site, Beijing

100044

GSK Investigational Site, Beijing

100071

GSK Investigational Site, Beijing

100142

GSK Investigational Site, Beijing

100191

GSK Investigational Site, Beijing

100730

GSK Investigational Site, Beijing

100853

GSK Investigational Site, Beijing

119074

GSK Investigational Site, Singapore

125101

GSK Investigational Site, Moscow

141008

GSK Investigational Site, Ludhiana

197022

GSK Investigational Site, Saint Petersburg

197110

GSK Investigational Site, Saint Petersburg

200025

GSK Investigational Site, Shanghai

200032

GSK Investigational Site, Shanghai

210029

GSK Investigational Site, Nanjing

215006

GSK Investigational Site, Jiang Su Province

250012

GSK Investigational Site, Jianan

300020

GSK Investigational Site, Tianjin

310003

GSK Investigational Site, Hangzhou

350014

GSK Investigational Site, Fuzhou

411001

GSK Investigational Site, Pune

510060

GSK Investigational Site, Guangzhou

510080

GSK Investigational Site, Guangzhou

510515

GSK Investigational Site, Guangzhou

610041

GSK Investigational Site, Chengdu

632004

GSK Investigational Site, Vellore

06520

GSK Investigational Site, New Haven

60612-7323

GSK Investigational Site, Chicago

39216-4505

GSK Investigational Site, Jackson

27599-7305

GSK Investigational Site, Chaple Hill

02908

GSK Investigational Site, Providence

C1426ANZ

GSK Investigational Site, Capital Federal

C1431FWO

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

B1900AXI

GSK Investigational Site, La Plata

A-5020

GSK Investigational Site, Salzburg

625 00

GSK Investigational Site, Brno

Unknown

GSK Investigational Site, Hradec Králové

GSK Investigational Site, Galway

GSK Investigational Site, Gothenburg

8000 C

GSK Investigational Site, Aarhus

00029

GSK Investigational Site, Helsinki

11 527

GSK Investigational Site, Athens

466-8650

GSK Investigational Site, Aichi

010-8543

GSK Investigational Site, Akita

811-1395

GSK Investigational Site, Fukuoka

060-8648

GSK Investigational Site, Hokkaido

650-0047

GSK Investigational Site, Hyōgo

305-8576

GSK Investigational Site, Ibaraki

236-0004

GSK Investigational Site, Kanagawa

259-1143

GSK Investigational Site, Kanagawa

602-8566

GSK Investigational Site, Kyoto

980-8574

GSK Investigational Site, Miyagi

390-8621

GSK Investigational Site, Nagano

852-8501

GSK Investigational Site, Nagasaki

700-8558

GSK Investigational Site, Okayama

589-8511

GSK Investigational Site, Osaka

329-0498

GSK Investigational Site, Tochigi

770-8503

GSK Investigational Site, Tokushima

104-0045

GSK Investigational Site, Tokyo

113-8655

GSK Investigational Site, Tokyo

135-8550

GSK Investigational Site, Tokyo

162-8655

GSK Investigational Site, Tokyo

3818 ES

GSK Investigational Site, Amersfoort

1066 CX

GSK Investigational Site, Amsterdam

1081 HV

GSK Investigational Site, Amsterdam

1105 AZ

GSK Investigational Site, Amsterdam

7511JX

GSK Investigational Site, Enschede

9713 GZ

GSK Investigational Site, Groningen

2134 TM

GSK Investigational Site, Hoofddorp

2333 ZA

GSK Investigational Site, Leiden

6229 HX

GSK Investigational Site, Maastricht

3435 CM

GSK Investigational Site, Nieuwegein

6525 GA

GSK Investigational Site, Nijmegen

3015 CE

GSK Investigational Site, Rotterdam

3075 EA

GSK Investigational Site, Rotterdam

3079 DZ

GSK Investigational Site, Rotterdam

6162 BG

GSK Investigational Site, Sittard-geleen

2545 CH

GSK Investigational Site, The Hague

3584 CX

GSK Investigational Site, Utrecht

8025 AB

GSK Investigational Site, Zwolle

0310

GSK Investigational Site, Oslo

41-500

GSK Investigational Site, Chorzów

80-952

GSK Investigational Site, Gdansk

60-833

GSK Investigational Site, Poznan

02-776

GSK Investigational Site, Warsaw

02-781

GSK Investigational Site, Warsaw

50-367

GSK Investigational Site, Wroclaw

519-809

GSK Investigational Site, Jellanamdo

120-752

GSK Investigational Site, Seoul

135-710

GSK Investigational Site, Seoul

08041

GSK Investigational Site, Barcelona

SE-221 85

GSK Investigational Site, Lund

SE-141 86

GSK Investigational Site, Stockholm

SE-751 85

GSK Investigational Site, Uppsala

B15 2TH

GSK Investigational Site, Birmingham

FY3 8NR

GSK Investigational Site, Blackpool

BS2 8ED

GSK Investigational Site, Bristol

CB2 2XY

GSK Investigational Site, Cambridge

GL53 7AN

GSK Investigational Site, Cheltenham

EH4 2XU

GSK Investigational Site, Edinburgh

G12 0YN

GSK Investigational Site, Glasgow

OX3 7LE

GSK Investigational Site, Headington, Oxford

LS9 7TF

GSK Investigational Site, Leeds

L7 8XP

GSK Investigational Site, Liverpool

NW1 2PG

GSK Investigational Site, London

NW3 2QG

GSK Investigational Site, London

SE5 9RS

GSK Investigational Site, London

W12 0HS

GSK Investigational Site, London

M13 9WL

GSK Investigational Site, Manchester

M20 4BX

GSK Investigational Site, Manchester

NE7 7DN

GSK Investigational Site, Newcastle upon Tyne

HA6 2RN

GSK Investigational Site, Northwood

NG5 1PB

GSK Investigational Site, Nottingham

S10 2JF

GSK Investigational Site, Sheffield

SO16 6YD

GSK Investigational Site, Southampton

CF14 2TL

GSK Investigational Site, Whitchurch, Cardiff

WV10 OQP

GSK Investigational Site, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01014208 - Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma | Biotech Hunter | Biotech Hunter