Clinical trial NCT01564784: A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Official title: AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
First posted: 2012-03-28
Enrollment: 326
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: This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.


Eligibility criteria: Inclusion Criteria:

* CD22 expression
* Adequate liver and renal functions

Exclusion Criteria:

* Isolated extramedullary disease
* Active Central Nervous System \[CNS\] disease

Primary outcomes:
measure: Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
timeFrame: Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
measure: Overall Survival (OS)
timeFrame: Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
Secondary outcomes:
measure: Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
timeFrame: Up to 2 years from randomization
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years from randomization
measure: Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
timeFrame: Up to 19 weeks from last dose
measure: Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
timeFrame: Up to approximately 4 weeks (EoT) from last dose of study drug
measure: Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
timeFrame: Up to approximately 4 weeks (EoT) from last dose of study drug
measure: Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
timeFrame: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
timeFrame: Day 1 of each cycle prior to dosing and EoT
measure: Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
timeFrame: Day 1 of each cycle prior to dosing and EoT
measure: Change From Baseline in EQ-5D VAS
timeFrame: Day 1 of each cycle prior to dosing and EoT
measure: Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
timeFrame: Up to 2 years from randomization
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Investigational Drug Services - UC San Diego Moores Cancer Center
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center - La Jolla
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Drug Information/Investigation Drug
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Rrmc
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Freidenrich Center for Translational Research (CTRU), Stanford University
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center - Hillcrest
state: California
city: Stanford
country: United States
facility: Martha Hamilton, Investigational Drug Services, Dept of Pharmacy
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Stanford
country: United States
facility: Stanford University Hospital and Clinics
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital, Cancer Center Infusion Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale-New Haven Hospital & Smilow Cancer Center
state: Connecticut
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Heart Health Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Investigational Drug Service, Emory University Clinic
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Atlanta
country: United States
facility: Blood and Marrow Transplant Group of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medicine Developmental Therapeutics Institute
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center, Dept. of Pharmacy
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Suburban
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Oncology Investigational Drug Service
state: Maryland
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System-
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Albuquerque
country: United States
facility: UNM Cancer Center
state: New Mexico
city: Lake Success
country: United States
facility: Monter Cancer Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York-Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical 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: Division of Hematology/Oncology, Stony Brook University Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Cancer Hospital Infusion Pharmacy
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Hospitals - The University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: OU Medical Center Presbyterian Tower
state: Oklahoma
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Hershey
country: United States
facility: IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center,
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: MUSC Hospital
state: South Carolina
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Universtiy Hospital - William P Clements Jr.
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital- Zale Lipshy
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals Pharmaceutical Services
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit, Box Hill Hospital
state: Victoria
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hostipal
state: Henan
city: Changchun
country: China
facility: The first hospital of jilin university
state: Jilin
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: The 307th Hospital of PLA
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,
city: Brno
country: Czechia
facility: Interni Hematologicka a Onkologicka Klinika
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Helsinki
country: Finland
facility: HUS-Kuvantaminen
city: Helsinki
country: Finland
facility: HYKS/Hematologian klinikka
city: Dijon
country: France
facility: CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique
city: Grenoble Cedex 09
country: France
facility: C.H.U. de Grenoble, Hopital Albert Michallon
city: Le Chesnay Cedex
country: France
facility: Hopital Universitaire Andre Mignot
city: Limoges Cedex
country: France
facility: CHU Dupuytren
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint Priest en Jarez Cedex
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Toulouse Cedex 9
country: France
facility: Iuct - Oncopole
city: Vandoeuvre-les-Nancy
country: France
facility: CHU Brabois- Service d'hematologie
city: Muenster
country: Germany
facility: Zentralapotheke des Universitaetsklinikums Muenster
state: Nordrhein-westfalen
city: Frankfurt
country: Germany
facility: Klinikum der Goethe Universitaet
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Köln
country: Germany
facility: Universitätsklinikum Köln, Klinik I für Innere Medizin
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar der TU München
city: Muenster
country: Germany
facility: Institut fuer klinische Radiologie
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Budapest
country: Hungary
facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu CTMO P.O. Businco
state: CA
city: Cagliari
country: Italy
facility: Farmacia
state: CA
city: Cagliari
country: Italy
facility: U.O. Radiodiagnostica
state: CA
city: Meldola (FC)
country: Italy
facility: IRST-Ematologia
state: FC
city: Bologna
country: Italy
facility: Istituto di Ematologia Seragnoli
city: Catania
country: Italy
facility: A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
city: Catania
country: Italy
facility: Radiology (Radiology Only)
city: Cona, Ferrara
country: Italy
facility: U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna
city: Genova
country: Italy
facility: Clinica Ematologica
city: Genova
country: Italy
facility: Pharmacy
city: Genova
country: Italy
facility: Radiology Department (Radiology ONLY)
city: Genova
country: Italy
facility: Radiology Department
city: Genova
country: Italy
facility: U.O. Ematologia 1
city: Milano
country: Italy
facility: S.C. Pharmacy
city: Milano
country: Italy
facility: S.C. Radiology
city: Milano
country: Italy
facility: SC Ematologia
city: Monza
country: Italy
facility: A.O. San Gerardo - Farmacia
city: Monza
country: Italy
facility: A.O. San Gerardo di Monza
city: Napoli
country: Italy
facility: AORN "A. Cardarelli"
city: Napoli
country: Italy
facility: RAdiology Department (RAdiology only)
city: Pavia
country: Italy
facility: Clinica Ematologica
city: Ravenna
country: Italy
facility: Radiologist Department
city: Ravenna
country: Italy
facility: Servizio di Farmacia
city: Ravenna
country: Italy
facility: U.O. Ematologia, Ospedale S. Maria delle Croci
city: Udine
country: Italy
facility: Clinica Ematologica
city: Udine
country: Italy
facility: Radiology (Radiology Only)
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
state: Aichi
city: Nishinomiya-shi
country: Japan
facility: The Hospital of Hyogo College of Medicine
state: Hyogo
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka-city
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Hwasun-Gun
country: Korea, Republic of
facility: Chonnam National University, Hwasun Hospital
state: Jeonnam
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South Holland
city: Gdansk
country: Poland
facility: Klinika Hematologii i Transplantologii
city: Lodz
country: Poland
facility: Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital
city: Warsaw
country: Poland
facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
city: Singapore
country: Singapore
facility: National University Hospital/National University Cancer Institute Singapore (NCIS)
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castille AND LION
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Catalonia
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Mallorca
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Murcia
country: Spain
facility: Hospital General Universitario Jose Maria Morales Meseguer
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Lund
country: Sweden
facility: Universitetssjukhus Lund, Hematologkliniken
city: Stockholm
country: Sweden
facility: Hematology Center
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation, Kaohsiung Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: London
country: United Kingdom
facility: Department of Academic Oncology
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Stelljes M, Advani AS, DeAngelo DJ, Wang T, Neuhof A, Vandendries E, Kantarjian H, Jabbour E. Time to First Subsequent Salvage Therapy in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin in the Phase III INO-VATE Trial. Clin Lymphoma Myeloma Leuk. 2022 Sep;22(9):e836-e843. doi: 10.1016/j.clml.2022.04.022. Epub 2022 Apr 27.
citation: Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.
citation: Kantarjian HM, Stock W, Cassaday RD, DeAngelo DJ, Jabbour E, O'Brien SM, Stelljes M, Wang T, Paccagnella ML, Nguyen K, Sleight B, Vandendries E, Neuhof A, Laird AD, Advani AS. Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22. Clin Cancer Res. 2021 May 15;27(10):2742-2754. doi: 10.1158/1078-0432.CCR-20-2399. Epub 2021 Feb 18.
citation: Stock W, Martinelli G, Stelljes M, DeAngelo DJ, Gokbuget N, Advani AS, O'Brien S, Liedtke M, Merchant AA, Cassaday RD, Wang T, Zhang H, Vandendries E, Jabbour E, Marks DI, Kantarjian HM. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia. Cancer. 2021 Mar 15;127(6):905-913. doi: 10.1002/cncr.33321. Epub 2020 Nov 24.
citation: DeAngelo DJ, Advani AS, Marks DI, Stelljes M, Liedtke M, Stock W, Gokbuget N, Jabbour E, Merchant A, Wang T, Vandendries E, Neuhof A, Kantarjian H, O'Brien S. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020 Aug 7;10(8):81. doi: 10.1038/s41408-020-00345-8.
citation: Jabbour E, Gokbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 Jan;88:106283. doi: 10.1016/j.leukres.2019.106283. Epub 2019 Nov 25.
citation: Fujishima N, Uchida T, Onishi Y, Jung CW, Goh YT, Ando K, Wang MC, Ono C, Matsumizu M, Paccagnella ML, Sleight B, Vandendries E, Fujii Y, Hino M. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol. 2019 Dec;110(6):709-722. doi: 10.1007/s12185-019-02749-0. Epub 2019 Nov 13.
citation: Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gokbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487. doi: 10.1002/cncr.32116. Epub 2019 Mar 28.
citation: Jabbour EJ, DeAngelo DJ, Stelljes M, Stock W, Liedtke M, Gokbuget N, O'Brien S, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS, Kantarjian HM. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Apr 15;124(8):1722-1732. doi: 10.1002/cncr.31249. Epub 2018 Jan 30.
citation: Kebriaei P, Cutler C, de Lima M, Giralt S, Lee SJ, Marks D, Merchant A, Stock W, van Besien K, Stelljes M. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12.
citation: Kantarjian HM, DeAngelo DJ, Advani AS, Stelljes M, Kebriaei P, Cassaday RD, Merchant AA, Fujishima N, Uchida T, Calbacho M, Ejduk AA, O'Brien SM, Jabbour EJ, Zhang H, Sleight BJ, Vandendries ER, Marks DI. Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. Lancet Haematol. 2017 Aug;4(8):e387-e398. doi: 10.1016/S2352-3026(17)30103-5. Epub 2017 Jul 4.
citation: Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gokbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.