Clinical trial NCT01232556: A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Official title: AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: inotuzumab ozogamicin
aggressive Non-Hodgkin lymphoma
diffuse large b-cell lymphoma
relapsed/refractory lymphoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
First posted: 2010-11-02
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
measure: Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
timeFrame: Up to 20 weeks after the first dose of study drug
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
measure: Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL
timeFrame: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
measure: Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL
timeFrame: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
measure: Duration of Response
timeFrame: Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
measure: Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire
timeFrame: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
measure: Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire
timeFrame: Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Disney Family Cancer Center at Providence St Joseph Medical Center
state: California
city: Burbank
country: United States
facility: Providence St Joseph Medical Center
state: California
city: Fresno
country: United States
facility: Hematology-Oncology Medical Group of Fresno Inc
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
state: California
city: Los Angeles
country: United States
facility: Clinical Research Unit
state: California
city: Los Angeles
country: United States
facility: Peter Morton Medical Plaza
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Hematology Oncology
state: California
city: Solvang
country: United States
facility: Sansum Clinic
state: California
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Aventura
country: United States
facility: Mount Sinai Comprehensive Cancer Center at Aventura
state: Florida
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Fernandina Beach
country: United States
facility: 21st Century Oncology of Jacksonville, LLC
state: Florida
city: Gainesville
country: United States
facility: Davis Cancer Pavilion and Shands Medical Plaza
state: Florida
city: Gainesville
country: United States
facility: Shands Cancer Hospital at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Health Davis Cancer Pavillion and Shands Med Plaza
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands Cancer Hospital
state: Florida
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology of Jacksonville, LLC
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology of Jacksonville, LLC
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology of Jacksonville, LLC
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology of Jacksonville, Inc.
state: Florida
city: Lake Worth
country: United States
facility: Medical Specialists Of The Palm Beaches
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Miami
country: United States
facility: Mercy Research Institute
state: Florida
city: Orange Park
country: United States
facility: 21st Century Oncology of Jacksonville, LLC
state: Florida
city: Augusta
country: United States
facility: Georgia Regents Medical Cancer Pharmacy
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Decatur
country: United States
facility: Decatur Memorial Hospital (DMH)
state: Illinois
city: New Albany
country: United States
facility: Floyd Memorial Cancer Center of Indiana
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky A.B. Chandler Medical Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Barbara Ann Karmanos Cancer Institute at farmington Hills
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Peters
country: United States
facility: Barnes-Jewish St. Peters
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
state: Nebraska
city: New York
country: United States
facility: Beth Israel Medical Center;
state: New York
city: New York
country: United States
facility: Beth Israel Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: St Luke's- Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center, The Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
city: West Chester
country: United States
facility: West Chester Hospital Medical Building
state: Ohio
city: Oklahoma City
country: United States
facility: OU Medical Center Presbyterian Professional Building
state: Oklahoma
city: Oklahoma City
country: United States
facility: OU Medical Center Presbyterian Tower
state: Oklahoma
city: Oklahoma City
country: United States
facility: Peggy and Charles Stephenson Cancer Center (chemo & infusion)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Peggy and Charles Stephenson Cancer Center (clinic location)
state: Oklahoma
city: Corvallis
country: United States
facility: Good Samaritan Hospital Corvallis
state: Oregon
city: Corvallis
country: United States
facility: Good Samaritan Hospital, Corvallis
state: Oregon
city: Corvallis
country: United States
facility: Samaritan Ambulatory Infusion Services
state: Oregon
city: Newport
country: United States
facility: Samaritan Pacific Coast Hospital
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic, Ltd.
state: Pennsylvania
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Oncology Group
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Oncology Group
state: Tennessee
city: Maryville
country: United States
facility: Thompson Oncology Group
state: Tennessee
city: Sevierville
country: United States
facility: Thompson Oncology Group
state: Tennessee
city: Dallas
country: United States
facility: University Hospital - St. Paul
state: Texas
city: Dallas
country: United States
facility: University Hospital - Zale Lipshy
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor: Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
state: Vlaams Brabant
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen
city: Wilrijk
country: Belgium
facility: St Augustinus Ziekenhuis
city: Yvoir
country: Belgium
facility: Cliniques universitaires UCL de Mont-Godinne,
city: Plovdiv
country: Bulgaria
facility: UMBAL Sveti Georgi, Klinika po hematologia
city: Sofia
country: Bulgaria
facility: SBAL na Hematologichnichni Zabolyavania,CTH Sofia
city: Sofia
country: Bulgaria
facility: Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont
state: Quebec
city: Zagreb
country: Croatia
facility: University Hospital Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Dubrava Department of Internal Medicine Division of Hematology
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Czech Republic
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Marseille
country: France
facility: Département Pharmacie
state: Bouches-du-rhône
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Cedex 09
city: Le Chesnay Cedex
country: France
facility: Hospital Universitaire Andre Mignot
state: Yvelines
city: Le Chesnay
country: France
facility: Hopital Andre Mignot
state: Yvelines
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: CHU Saint Eloi
city: Pessac
country: France
facility: Hopital du haut Leveque
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg
city: Berlin
country: Germany
facility: Charite Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum
city: Mainz
country: Germany
facility: Universitaetsklinikum Mainz
city: Muenchen
country: Germany
facility: TU Muenchen III. Medizinische Klinik
city: Ulm
country: Germany
facility: Universitaetsklinik Ulm
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz /
city: Debrechen
country: Hungary
facility: DEOEC, Belgyogyaszati Intezet
city: Kaposvar
country: Hungary
facility: Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly
city: Aurangabad
country: India
facility: Kodlikeri Memorial Hospital
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Clinical Research and Development Center
state: Maharashtra
city: Pune
country: India
facility: OEC Record Management Company Pvt. Ltd.,
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Speciality Hospital
state: Maharashtra
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Maebashi-city
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Moriguchi
country: Japan
facility: Matsushita Memorial Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Klaipeda
country: Lithuania
facility: Klaipeda Seamen's Hospital, Public Institution, department of Oncology
city: Aguascalientes
country: Mexico
facility: Instituto Biomédico de Investigación A.C.
state: Aguascalientes. Mexico
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa
city: Warszawa
country: Poland
facility: Klinika Nowotworow Ukladu Chlonnego
city: Catano
country: Puerto Rico
facility: Advanced Infusion Services
city: San Juan
country: Puerto Rico
facility: Hospital Espanol Auxilio Mutuo de Puerto Rico Inc
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution Hematology Scientific Centre of Ministry of
city: Moscow
country: Russian Federation
facility: Moscow State Healthcare Institution City clinical hospital S.P. Botkin
city: Saint-Petersburg
country: Russian Federation
facility: Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
state: Andalucia
city: Salamanca
country: Spain
facility: Hospital Universitario De Salamanca
state: Castille AND LION
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari de Barcelona
city: L'Hospitalet De Llobregat (bcn)
country: Spain
facility: Institut Catala d'Oncologia-L'Hospitalet
city: La Laguna (Tenerife)
country: Spain
facility: Hospital Universitario de Canarias
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Linkoping
country: Sweden
facility: Universitetssjukhuset
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus i Lund
city: Kuei-Shan Hsiang
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou Branch
state: Taoyuan County
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Department of Internal Medicine
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkoknoi
country: Thailand
facility: Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University
state: Bangkok
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Cherkasy
country: Ukraine
facility: Regional Treatment and Diagnostic Hematology Center Communal Establishment
city: Dnipropetrovsk
country: Ukraine
facility: Department of Oncology and Medical Radiology of State Institution
city: Kyiv
country: Ukraine
facility: SI"Research Center for Radiation Medicine of NAMS of Ukraine"
city: London
country: United Kingdom
facility: Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust
city: London
country: United Kingdom
facility: Chemotherapy Preparative Unit St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: Department of Medical Oncology St. Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust - Christie Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I
city: Newcastle upon Tyne
country: United Kingdom
facility: Department of Clinical Biochemistry Newcastle upon Tyne Hospitals
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Nottingham
country: United Kingdom
facility: Pathology Department Nottingham University Hospital - City Hospital Campus
city: Nottingham
country: United Kingdom
facility: Pharmacy Nottingham University Hospital - City Hospital Campus
city: Nottingham
country: United Kingdom
facility: Local Laboratory Nottingham University Hospital - City Hospital Campus
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: