A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

PHASE3TerminatedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

April 4, 2011

Primary Completion Date

March 28, 2014

Study Completion Date

March 28, 2014

Conditions
Lymphoma, Non-Hodgkin
Interventions
DRUG

Inotuzumab ozogamicin

1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles

DRUG

Rituximab

375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles

DRUG

rituximab + gemcitabine

rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles

DRUG

rituximab +bendamustine

rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

Trial Locations (177)

100

National Taiwan University Hospital, Department of Internal Medicine, Taipei

333

Chang Gung Medical Foundation - Linkou Branch, Kuei-Shan Hsiang

1000

Institut Jules Bordet, Brussels

1097

Egyesitett Szent Istvan es Szent Laszlo Korhaz /, Budapest

1756

SBAL na Hematologichnichni Zabolyavania,CTH Sofia, Sofia

Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia, Sofia

2610

St Augustinus Ziekenhuis, Wilrijk

3000

Universitaire Ziekenhuizen Leuven, Leuven

4002

UMBAL Sveti Georgi, Klinika po hematologia, Plovdiv

4032

DEOEC, Belgyogyaszati Intezet, Debrechen

5530

Cliniques universitaires UCL de Mont-Godinne,, Yvoir

6000

Grand Hopital de Charleroi, Charleroi

7400

Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly, Kaposvár

8800

H.-Hartziekenhuis Roeselare-Menen, Roeselare

10000

University Hospital Zagreb, Zagreb

10003

Beth Israel Medical Center;, New York

10010

University Hospital Dubrava Department of Internal Medicine Division of Hematology, Zagreb

10019

St Luke's- Roosevelt Hospital Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10117

Charite Campus Benjamin Franklin, Berlin

10700

Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University, Bangkoknoi

11217

Taipei Veterans General Hospital, Taipei

11794

Stony Brook University Medical Center, The Cancer Center, Stony Brook

Stony Brook University Medical Center, Stony Brook

13273

Institut Paoli Calmettes, Marseille

13353

Charite Campus Virchow-Klinikum, Berlin

17033

Penn State Milton S. Hershey Medical Center, Hershey

18009

Regional Treatment and Diagnostic Hematology Center Communal Establishment, Cherkasy

18840

Guthrie Clinic, Ltd., Sayre

Robert Packer Hospital, Sayre

20060

Howard University Hospital, Washington D.C.

20127

Instituto Biomédico de Investigación A.C., Aguascalientes

28006

Hospital de la Princesa, Madrid

30912

Georgia Regents Medical Cancer Pharmacy, Augusta

Georgia Regents University, Augusta

32034

21st Century Oncology of Jacksonville, LLC, Fernandina Beach

32073

21st Century Oncology of Jacksonville, LLC, Orange Park

32205

21st Century Oncology of Jacksonville, LLC, Jacksonville

32207

21st Century Oncology of Jacksonville, LLC, Jacksonville

Baptist Cancer Institute, Jacksonville

Baptist Medical Center, Jacksonville

32256

21st Century Oncology of Jacksonville, LLC, Jacksonville

32258

21st Century Oncology of Jacksonville, Inc., Jacksonville

32608

Davis Cancer Pavilion and Shands Medical Plaza, Gainesville

Shands Cancer Hospital at the University of Florida, Gainesville

UF Health Davis Cancer Pavillion and Shands Med Plaza, Gainesville

UF Health Shands Cancer Hospital, Gainesville

32610

Shands Hospital at the University of Florida, Gainesville

UF Health Shands Hospital, Gainesville

33133

Advanced Medical Specialties, Miami

Mercy Hospital, Miami

Mercy Research Institute, Miami

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

Mount Sinai Medical Center, Miami Beach

33180

Mount Sinai Comprehensive Cancer Center at Aventura, Aventura

33426

University Cancer Institute, Boynton Beach

33467

Medical Specialists Of The Palm Beaches, Lake Worth

33600

Hopital du haut Leveque, Pessac

37007

Hospital Universitario De Salamanca, Salamanca

37804

Thompson Oncology Group, Maryville

37862

Thompson Oncology Group, Sevierville

37916

Thompson Oncology Group, Knoxville

37932

Thompson Oncology Group, Knoxville

38320

Hospital Universitario de Canarias, La Laguna (Tenerife)

40536

University of Kentucky A.B. Chandler Medical Center, Lexington

University of Kentucky Markey Cancer Center, Lexington

40705

Taichung Veterans General Hospital, Taichung

41013

Hospital Virgen Del Rocio, Seville

45069

West Chester Hospital Medical Building, West Chester

45219

University Hospital, Cincinnati

47150

Floyd Memorial Cancer Center of Indiana, New Albany

48201

Barbara Ann Karmanos Cancer Institute, Detroit

48334

Barbara Ann Karmanos Cancer Institute at farmington Hills, Farmington Hills

49102

Department of Oncology and Medical Radiology of State Institution, Dnipropetrovsk

50200

Chiang Mai University, Chiang Mai

52074

Universitaetsklinikum Aachen, Aachen

55101

Universitaetsklinikum Mainz, Mainz

55426

Park Nicollet Frauenshuh Cancer Center, Saint Louis Park

58185

Universitetssjukhuset, Linköping

62500

Fakultni nemocnice Brno, Brno

62526

Decatur Memorial Hospital (DMH), Decatur

63110

Barnes-Jewish Hospital, St Louis

Washington University in St Louis, St Louis

Washington University School of Medicine, St Louis

Washington University, St Louis

63376

Barnes-Jewish St. Peters, City of Saint Peters

66160

University of Kansas Medical Center, Kansas City

66205

University of Kansas Cancer Center and Medical Pavilion, Westwood

68510

Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center, Lincoln

69373

Centre Leon Berard, Lyon

70112

Tulane University Hospital and Clinic, New Orleans

73104

OU Medical Center Presbyterian Professional Building, Oklahoma City

OU Medical Center Presbyterian Tower, Oklahoma City

Peggy and Charles Stephenson Cancer Center (chemo & infusion), Oklahoma City

Peggy and Charles Stephenson Cancer Center (clinic location), Oklahoma City

75235

University Hospital - St. Paul, Dallas

University Hospital - Zale Lipshy, Dallas

75246

Baylor University Medical Center, Dallas

Baylor: Charles A. Sammons Cancer Center, Dallas

75390

Simmons Comprehensive Cancer Center, Dallas

76038

Centre Henri Becquerel, Rouen

77030

The University of Texas MD Anderson Cancer Center, Houston

78157

Hopital Andre Mignot, Le Chesnay

Hospital Universitaire Andre Mignot, Le Chesnay

81675

TU Muenchen III. Medizinische Klinik, München

83814

Kootenai Cancer Center, Coeur d'Alene

89081

Universitaetsklinik Ulm, Ulm

90095

Clinical Research Unit, Los Angeles

Peter Morton Medical Plaza, Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles

90404

UCLA Santa Monica Hematology Oncology, Santa Monica

91505

Disney Family Cancer Center at Providence St Joseph Medical Center, Burbank

Providence St Joseph Medical Center, Burbank

92288

Klaipeda Seamen's Hospital, Public Institution, department of Oncology, Klaipėda

93105

Sansum Clinic, Santa Barbara

93463

Sansum Clinic, Solvang

93720

Hematology-Oncology Medical Group of Fresno Inc, Fresno

96049

Sozialstiftung Bamberg, Bamberg

97330

Good Samaritan Hospital Corvallis, Corvallis

Good Samaritan Hospital, Corvallis, Corvallis

Samaritan Ambulatory Infusion Services, Corvallis

97365

Samaritan Pacific Coast Hospital, Newport

119074

National University Hospital, Singapore

125167

Federal State Budgetary Institution Hematology Scientific Centre of Ministry of, Moscow

125284

Moscow State Healthcare Institution City clinical hospital S.P. Botkin, Moscow

169608

Singapore General Hospital, Singapore

197022

Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva, Saint Petersburg

411004

OEC Record Management Company Pvt. Ltd.,, Pune

Sahyadri Speciality Hospital, Pune

4668650

Nagoya Daini Red Cross Hospital, Nagoya

90095-6981

Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services, Los Angeles

083854

Kootenai Cancer Center, Post Falls

10011-5903

Beth Israel Comprehensive Cancer Center, New York

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

M4N 3 M5

Sunnybrook Health Sciences Centre, Toronto

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont, Sherbrooke

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

Cedex 09 13273

Département Pharmacie, Marseille

34295Cedex5

CHU Saint Eloi, Montpellier

431 005

Kodlikeri Memorial Hospital, Aurangabad

411 004

Sahyadri Clinical Research and Development Center, Pune

Unknown

Bon Secours Hospital, Cork

277-8577

National Cancer Center Hospital East, Kashiwa

791-0295

Ehime University Hospital, Toon-shi

371-8511

Gunma University Hospital, Maebashi

980-8574

Tohoku University Hospital, Sendai

570-8540

Matsushita Memorial Hospital, Moriguchi

411-8777

Shizuoka Cancer Center, Sunto-gun

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

Cancer Institute Hospital, Japanese Foundation For Cancer Research, Koto-Ku

010-8543

Akita University Hospital, Akita

811-1395

National Kyushu Cancer Center, Fukuoka

259-1193

Tokai University Hospital, Kanagawa

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

00-728

Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa, Warsaw

02-781

Klinika Nowotworow Ukladu Chlonnego, Warsaw

00962

Advanced Infusion Services, Cataño

00918

Hospital Espanol Auxilio Mutuo de Puerto Rico Inc, San Juan

833 10

Narodny onkologicky ustav, Bratislava

08036

Hospital Clinic de Barcelona, Barcelona

Hospital Clinic Universitari de Barcelona, Barcelona

08907

Institut Catala d'Oncologia-L'Hospitalet, L'Hospitalet de Llobregat (bcn)

221 85

Skanes Universitetssjukhus i Lund, Lund

03115

"SIResearch Center for Radiation Medicine of NAMS of Ukraine", Kyiv

EC1A 7BE

Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust, London

Chemotherapy Preparative Unit St. Bartholomew's Hospital, London

Department of Medical Oncology St. Bartholomew's Hospital, London

M20 4BX

The Christie NHS Foundation Trust - Christie Hospital, Manchester

NE1 4LP

Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I, Newcastle upon Tyne

NE7 7DN

Department of Clinical Biochemistry Newcastle upon Tyne Hospitals, Newcastle upon Tyne

Northern Centre for Cancer Care, Newcastle upon Tyne

NG5 1PB

Nottingham University Hospital, Nottingham

Pathology Department Nottingham University Hospital - City Hospital Campus, Nottingham

Pharmacy Nottingham University Hospital - City Hospital Campus, Nottingham

NG51PB

Local Laboratory Nottingham University Hospital - City Hospital Campus, Nottingham

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

UCB Pharma

INDUSTRY

lead

Pfizer

INDUSTRY