Spots Global Cancer Trial Database for Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
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Trial Identification
Brief Title: Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Official Title: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study ID: NCT02227251
Conditions
Study Description
Brief Summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.
Detailed Description: This is a multicenter, open label, Phase 2b study of the selective inhibitor of nuclear export (SINE) selinexor (40 or 60 milligrams \[mg\]) given orally (PO) to participants with R/R DLBCL). The study is being conducted in 2 parts (Part 1 and Part 2). For Part 1, a fixed 60 mg dose of selinexor is given orally to 130 participants with R/R DLBCL who have no therapeutic options of demonstrated clinical benefit and who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred. For Part 2, approximately 110 participants (55 in each arm) are planned to be enrolled. Participants will be randomized (open label) in a 1:1 ratio to either Arm A (40 mg) or Arm B (60 mg) and will be stratified based on history of prior autologous stem cell transplantation (ASCT) versus no prior ASCT. All the participants will be followed until disease progression and/or death.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UACC Arizona, Tucson, Arizona, United States
University of California San Francisco, San Francisco, California, United States
University of California Los Angeles (UCLA), Santa Monica, California, United States
Boca Raton Cancer Research Medical Center, Plantation, Florida, United States
University of Chicago, Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center/Northwestern University, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Tufts Medical Center, Boston, Massachusetts, United States
Lahey Clinic, Burlington, Massachusetts, United States
University of Massachusetts Medical School, Worcester, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Clinical Research Alliance, Lake Success, New York, United States
New York Presbyterian Hospital/ Cornell Medical College, New York, New York, United States
Stony Brook University Hospital, Stony Brook, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Greenville Hospital System, Greenville, South Carolina, United States
MD Anderson, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Virginia Mason Hospital & Medical Center, Seattle, Washington, United States
St. Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Liverpool Hospital, Ingham Institute of Medical Research, Liverpool, New South Wales, Australia
Calvary Mater Newcastle Hospital, Waratah, New South Wales, Australia
Icon Cancer Care, South Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Ashford Cancer Centre, Kurralta Park, South Australia, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Epworth Hospital, East Melbourne, Victoria, Australia
St. Vincent's Melbourne, Fitzroy, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Medical University of Graz, Graz, , Austria
Medizinische UniversitĂ€t Innsbruck fĂŒr Innere Medizin, Innsbruck, , Austria
LKH Leoben Department for Haemato-Oncology, Leoben, , Austria
Akh Linz Innere Med III - Zentrum fĂŒr HĂ€matologie und med. Onkologie, Linz, , Austria
Krankenhaus Barmherzigen Schwestern Linz, Linz, , Austria
Krankenhaus der Elisabethinen Linz GmbH, Linz, , Austria
Uni. Klinik fĂŒr Innere Medizin III UniversitĂ€tsklinikum der PMU LKH Salzburg, Salzburg, , Austria
Medical University of Vienna (MUW) Department of Medicine I, Vienna, , Austria
Univ. General Hospital Hietzing, Vienna, , Austria
Ziekenhuis Netwerk Antwerpen, Antwerpen, , Belgium
AZ Sint-Jan, Bruges, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
UZ Gent, Gent, , Belgium
CH Jolimont, La Louviere, , Belgium
AZ Delta, Roeselare, , Belgium
H-Hartziekenhuis Roeselare-Menen, Roeselare, , Belgium
University Hospital for Active Treatment Dr. Georgi Stranski, Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases EAD, Sofia, , Bulgaria
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital/McGill University, Montreal, Quebec, Canada
CHU Lyon Sud, Pierre-BĂ©nite, Lyon, France
Centre Hospitalier Universitaire Henri Mondor, Créteil, , France
Unite Hemopathies Lymphoides Chu Henri Mondor, Créteil, , France
Chu Dijon-Bourgogne - Hematologie Clinique, Dijon, , France
Hospitalier de la Rochelle-RĂ©-Aunis, La Rochelle, , France
CHRU de Lille - Hopital Claude-Huriez, Lille, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, , France
CHU Montpellier, Montpellier, , France
Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie), Paris, , France
HĂŽpital Necker Service d'HĂ©matologie Adult, Paris, , France
PitiĂ©-SalpĂȘtriĂšre Hospital, Paris, , France
Centre Henri Becquerel, Rouen, , France
Uniklinik Aachen Klinik fĂŒr HĂ€matologie, Onkologie, HĂ€mostaseologie und Stammzelltransplantation, Aachen, , Germany
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
Charite Universitatsmedizin Berlin (Benjamin Franklin Campus), Berlin, , Germany
Charite Universitatsmedizin Berlin (Virchow Campus), Berlin, , Germany
Ev. Diakonie-Krankenhaus gGmbH, Bremen, , Germany
Gemeinschaftspraxis Haematologie and Onkologie-Dresden, Dresden, , Germany
Martin-Luther-University Halle-Wittenberg Department of Oncology, Halle, , Germany
Medizinische Hochschule, Hannover, , Germany
UniversitÀt Heidelberg Medizinische Klinik V HÀmatologie, Onkologie und Rheumatologie, Heidelberg, , Germany
Klinikum Kempten Klinik fĂŒr Innere Medizin III - HĂ€matologie, Onkologie und Palliativmedizin, Koln, , Germany
Klinikum Leverkusen, Leverkusen, , Germany
Klinikum Ludwigshafen, Ludwigshafen, , Germany
Rotkreuzklinikum MĂŒnchen, Muenchen, , Germany
Klinikum NĂŒrnberg Nord, Nuernberg, , Germany
Haematology Department and HCT Unit G.Papanicolaou Hospital, Exochi, Thessaloniki, Greece
Hematology Clinic,General Hospital of Athens,G. Gennimatos, Athens, , Greece
National & Kapodistrian University of Athens, Laiko General Hospital, Athens, , Greece
Hematology Department Laiko General Hospital, Athens, , Greece
Second Depth of Internal Medicine, Attiko University Hospital, Athens, , Greece
National & Kapodistrian University of Athens, Attiko University Hospital, Chaidari, , Greece
Department of clinical hematology ,university hospital Ioannina, IoĂĄnnina, , Greece
University of Patras Medical School, Patras, , Greece
Semmelweis Egyetem ĂltalĂĄnos Orvosi Kar, Budapest, , Hungary
Orszågos Onkológiai Intézet "A" Belgyógyåszati Onkológiai Osztåly, Budapest, , Hungary
Semmelweis University Department of Medicine and Oncology, Budapest, , Hungary
Somogy Megyei Kaposi MĂłr OktatĂł KĂłrhĂĄz, KaposvĂĄr, , Hungary
PĂ©csi TudomĂĄnyegyetem, ĂOK, I. szĂĄmĂș BelgyĂłgyĂĄszati Klinika, PĂ©cs, , Hungary
Veszprém Megyei Csolnoky Ferenc Kórhåz, Veszprém, , Hungary
CSolnoky ferenc Hospital, Veszprém, , Hungary
Regional Cancer Centre, IGIMS, Patna, Bihar, India
SRM Institutes for Medical Science, Vadapalani, Chennai, India
Rajiv Gandhi Cancer Hospital, New Delhi, Delhi, India
Regional Cancer Centre, Thiruvananthapuram, Kerala, India
Prince Aly Khan Hospital, Mumbai, Maharashtra, India
Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital, Pune, Maharashtra, India
Institute of Medical Sciences & SUM Hospital, Bhubaneswar, Odisha, India
Dayanand Medical College and Hospital, LudhiÄna, Punjab, India
Cancer Institute (WIA), Chennai, Tamil Nadu, India
Saveetha Medical College Hospital, Chennai, Tamil Nadu, India
G. Kuppu Swamy Naidu Hospital, Coimbatore, Tamil Nadu, India
Meenakshi Mission Hospital & Research Centre, Madurai, Tamil Nadu, India
King George's Medical University (KGMU), Lucknow, Uttar Pradesh, India
Nil Ratan Sircar Medical College and Hospital, Kolkata, West Bengal, India
Netaji Subhas Chandra Bose Cancer Research Hospital, Kolkata, West Bengal, India
TATA Memorial Centre, Kolkata, West Bengal, India
Netaji Subhas Chandra Bose Cancer Research Institute, Kolkata, West Bengal, India
IRCH, All India Institute of Medical Sciences, Delhi, , India
Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences, New Delhi, , India
Hematology-Soroka, Beer Sheva, , Israel
Rambam Healthcare Campus, Haifa, , Israel
Wolfson MC, Holon, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Assuta Medical Center, Tel Aviv, , Israel
TLV Sorasky Medical Center, Tel Aviv, , Israel
Sheba Medical Center, Tel Hashomer, , Israel
Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna, Bologna, , Italy
SODc Ematologica ,AOU Careggi, Florence, , Italy
AOU Maggiore della CaritĂ SCDU Ematologia, Florence, , Italy
Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS, Naples, , Italy
SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale, Novara, , Italy
Fondazione Policlinico Universitario A. Gemelli, Rome, , Italy
Azienda Ospedaliero-Universitaria Senese, Siena, , Italy
CittĂ della Salute e della Scienza di Torino, Torino, , Italy
VUMc (Vrije Universiteit Amsterdam), Amsterdam, , Netherlands
LUMC (leidse universitair medisch centrum), Leiden, , Netherlands
North Shore Hospital, Auckland, , New Zealand
Christchurch Hospital, Christchurch, , New Zealand
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza, WrocĆaw, Radeckiego, Poland
Szpitale WojewĂłdzkie w Gdyni, GdyĆskie Centrum onkologii, Gdynia, , Poland
MCM (MaĆopolskie Centrum Medyczne), Krakow, , Poland
Wojewodzki Szpital Specjalistyczny w Legnicy, Legnica, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland
Hematology Department St John's Cancer Centre, Lublin, , Poland
Samodzielny Publiczny ZakĆad Opieki Zdrowotnej Ministerstwa, Olsztyn, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Centrum Onkologii- Insytut Im. Marii SkĆodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego, Warszawa, , Poland
Maria Sklodowska Curie National Research Institute, Warszawa, , Poland
Memorial Provincial Specialist Hospital in Lodz, ĆĂłdĆș, , Poland
Institut za onkologiju i radiologiju Srbije, Belgrade, , Serbia
Klinicko Bolnick Centar Zemun Odeljenje hematologije, Belgrade, , Serbia
KliniÄki centar Srbije Klinika za hematologiju, Belgrade, , Serbia
KliniÄko bolniÄki centar Zvezdara, Belgrade, , Serbia
KliniÄki centar NiĆĄ Klinika za hematologiju, Nis, , Serbia
Institut za onkologiju Vojvodine, Sremska Kamenica, , Serbia
Hospitla Universitari Germans Trias i Pujol - ICO, Badalona, , Spain
Hospital University Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital de Son LlĂ tzer, Palma de Mallorca, , Spain
ClĂnica Universidad De Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Gloucestershire Royal Hospital, Gloucester, Gloucestershire, United Kingdom
Southampton University Hospital, Southampton, Hampshire, United Kingdom
Royal Marsden Hospital, Sutton, London, United Kingdom
Northwick Park Hospital, Harrow, Middlesex, United Kingdom
Leeds Teaching Hospitals NHS Trust, Leeds, Yorkshire, United Kingdom
Addenbrooke's Hospital Cambridge, Cambridge, , United Kingdom
Royal Liverpool University Hospital, Liverpool, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
King's College Hospital, London, , United Kingdom
Princess Royal University Hospital (PRUH), London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Contact Details
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