Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- Registration Number
- NCT02227251
- Lead Sponsor
- Karyopharm Therapeutics Inc
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 244
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Selinexor 60 mg Selinexor Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle). Part 2: Arm A-Selinexor 40 mg Selinexor Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle). Part 2: Arm B-Selinexor 60 mg Selinexor Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).
- Primary Outcome Measures
Name Time Method Part 2: Overall Response Rate (ORR) Based on Lugano Criteria From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization) Assessed according to the response assessment of lymphoma based on Lugano classification.
Part 1: Overall Response Rate (ORR) One year Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).
- Secondary Outcome Measures
Name Time Method Part 1: Disease Control Rate (DCR) From initial response until disease progression or death (maximum of 1 year from Part 1 randomization) Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization) Part 2: Disease control rate (DCR) From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization) Part 1: Duration of Response (DOR) From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization) Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization) Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization) Part 2: Duration of response (DOR) From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization) Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization) Part 2: Number of Participants with Treatment-emergent Adverse Events From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
Trial Locations
- Locations (176)
Lahey Clinic
๐บ๐ธBurlington, Massachusetts, United States
Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
Virginia Mason Hospital & Medical Center
๐บ๐ธSeattle, Washington, United States
Meenakshi Mission Hospital & Research Centre
๐ฎ๐ณMadurai, Tamil Nadu, India
Cancer Institute (WIA)
๐ฎ๐ณChennai, Tamil Nadu, India
LKH Leoben Department for Haemato-Oncology
๐ฆ๐นLeoben, Austria
Akh Linz Innere Med III - Zentrum fรผr Hรคmatologie und med. Onkologie
๐ฆ๐นLinz, Austria
Greenville Hospital System
๐บ๐ธGreenville, South Carolina, United States
Krankenhaus der Elisabethinen Linz GmbH
๐ฆ๐นLinz, Austria
Ziekenhuis Netwerk Antwerpen
๐ง๐ชAntwerpen, Belgium
University Hospital for Active Treatment Dr. Georgi Stranski
๐ง๐ฌPleven, Bulgaria
VUMc (Vrije Universiteit Amsterdam)
๐ณ๐ฑAmsterdam, Netherlands
Samodzielny Publiczny Zakลad Opieki Zdrowotnej Ministerstwa
๐ต๐ฑOlsztyn, Poland
The Alfred Hospital
๐ฆ๐บMelbourne, Victoria, Australia
Orszรกgos Onkolรณgiai Intรฉzet "A" Belgyรณgyรกszati Onkolรณgiai Osztรกly
๐ญ๐บBudapest, Hungary
Semmelweis University Department of Medicine and Oncology
๐ญ๐บBudapest, Hungary
Medizinische Universitรคt Innsbruck fรผr Innere Medizin
๐ฆ๐นInnsbruck, Austria
Sir Mortimer B Davis Jewish General Hospital/McGill University
๐จ๐ฆMontreal, Quebec, Canada
Haematology Department and HCT Unit G.Papanicolaou Hospital
๐ฌ๐ทExochi, Thessaloniki, Greece
National & Kapodistrian University of Athens, Laiko General Hospital
๐ฌ๐ทAthens, Greece
Monash Medical Centre
๐ฆ๐บClayton, Victoria, Australia
UACC Arizona
๐บ๐ธTucson, Arizona, United States
Medical University of Vienna (MUW) Department of Medicine I
๐ฆ๐นVienna, Austria
Institut Jules Bordet
๐ง๐ชBrussels, Belgium
Department of clinical hematology ,university hospital Ioannina
๐ฌ๐ทIoรกnnina, Greece
CSolnoky ferenc Hospital
๐ญ๐บVeszprรฉm, Hungary
MCM (Maลopolskie Centrum Medyczne)
๐ต๐ฑKrakow, Poland
Hematology Department St John's Cancer Centre
๐ต๐ฑLublin, Poland
Gloucestershire Royal Hospital
๐ฌ๐งGloucester, Gloucestershire, United Kingdom
Epworth Hospital
๐ฆ๐บEast Melbourne, Victoria, Australia
AZ Sint-Jan
๐ง๐ชBruges, Belgium
Cliniques Universitaires Saint-Luc
๐ง๐ชBrussels, Belgium
Assuta Medical Center
๐ฎ๐ฑTel Aviv, Israel
Wojewodzki Szpital Specjalistyczny w Legnicy
๐ต๐ฑLegnica, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
๐ต๐ฑLublin, Poland
H-Hartziekenhuis Roeselare-Menen
๐ง๐ชRoeselare, Belgium
Hematology Clinic,General Hospital of Athens,G. Gennimatos
๐ฌ๐ทAthens, Greece
Jaslok Hospital and Research Centre
๐ฎ๐ณMumbai, Maharashtra, India
Szpitale Wojewรณdzkie w Gdyni, Gdyลskie Centrum onkologii
๐ต๐ฑGdynia, Poland
Netaji Subhas Chandra Bose Cancer Research Hospital
๐ฎ๐ณKolkata, West Bengal, India
Hematology Department Laiko General Hospital
๐ฌ๐ทAthens, Greece
Prince Aly Khan Hospital
๐ฎ๐ณMumbai, Maharashtra, India
Instytut Hematologii i Transfuzjologii
๐ต๐ฑWarszawa, Poland
Semmelweis Egyetem รltalรกnos Orvosi Kar
๐ญ๐บBudapest, Hungary
Regional Cancer Centre
๐ฎ๐ณThiruvananthapuram, Kerala, India
Dayanand Medical College and Hospital
๐ฎ๐ณLudhiฤna, Punjab, India
Institut za onkologiju i radiologiju Srbije
๐ท๐ธBelgrade, Serbia
Kliniฤki centar Niลก Klinika za hematologiju
๐ท๐ธNis, Serbia
University of Oklahoma
๐บ๐ธOklahoma City, Oklahoma, United States
University of California Los Angeles (UCLA)
๐บ๐ธSanta Monica, California, United States
Boca Raton Cancer Research Medical Center
๐บ๐ธPlantation, Florida, United States
University of Chicago
๐บ๐ธChicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center/Northwestern University
๐บ๐ธChicago, Illinois, United States
John Theurer Cancer Center at Hackensack University Medical Center
๐บ๐ธHackensack, New Jersey, United States
Dana Farber Cancer Institute
๐บ๐ธBoston, Massachusetts, United States
University of Massachusetts Medical School
๐บ๐ธWorcester, Massachusetts, United States
Clinical Research Alliance
๐บ๐ธLake Success, New York, United States
New York Presbyterian Hospital/ Cornell Medical College
๐บ๐ธNew York, New York, United States
Stony Brook University Hospital
๐บ๐ธStony Brook, New York, United States
Gabrail Cancer Center
๐บ๐ธCanton, Ohio, United States
University Hospitals Seidman Cancer Center
๐บ๐ธCleveland, Ohio, United States
Swedish Cancer Institute
๐บ๐ธSeattle, Washington, United States
St. Vincent's Hospital Sydney
๐ฆ๐บDarlinghurst, New South Wales, Australia
MD Anderson
๐บ๐ธHouston, Texas, United States
Calvary Mater Newcastle Hospital
๐ฆ๐บWaratah, New South Wales, Australia
Royal Adelaide Hospital
๐ฆ๐บAdelaide, South Australia, Australia
Fiona Stanley Hospital
๐ฆ๐บMurdoch, Western Australia, Australia
Medical University of Graz
๐ฆ๐นGraz, Austria
Krankenhaus Barmherzigen Schwestern Linz
๐ฆ๐นLinz, Austria
Univ. General Hospital Hietzing
๐ฆ๐นVienna, Austria
Uni. Klinik fรผr Innere Medizin III Universitรคtsklinikum der PMU LKH Salzburg
๐ฆ๐นSalzburg, Austria
UZ Gent
๐ง๐ชGent, Belgium
CH Jolimont
๐ง๐ชLa Louviere, Belgium
AZ Delta
๐ง๐ชRoeselare, Belgium
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
๐ง๐ฌSofia, Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases EAD
๐ง๐ฌSofia, Bulgaria
Princess Margaret Cancer Centre
๐จ๐ฆToronto, Ontario, Canada
CHU Lyon Sud
๐ซ๐ทPierre-Bรฉnite, Lyon, France
Centre Hospitalier Universitaire Henri Mondor
๐ซ๐ทCrรฉteil, France
Chu Dijon-Bourgogne - Hematologie Clinique
๐ซ๐ทDijon, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
๐ซ๐ทMarseille, France
Hospitalier de la Rochelle-Rรฉ-Aunis
๐ซ๐ทLa Rochelle, France
CHRU de Lille - Hopital Claude-Huriez
๐ซ๐ทLille, France
CHU Montpellier
๐ซ๐ทMontpellier, France
Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)
๐ซ๐ทParis, France
Pitiรฉ-Salpรชtriรจre Hospital
๐ซ๐ทParis, France
Uniklinik Aachen Klinik fรผr Hรคmatologie, Onkologie, Hรคmostaseologie und Stammzelltransplantation
๐ฉ๐ชAachen, Germany
Centre Henri Becquerel
๐ซ๐ทRouen, France
HELIOS Klinikum Bad Saarow
๐ฉ๐ชBad Saarow, Germany
Ev. Diakonie-Krankenhaus gGmbH
๐ฉ๐ชBremen, Germany
Gemeinschaftspraxis Haematologie and Onkologie-Dresden
๐ฉ๐ชDresden, Germany
Klinikum Nรผrnberg Nord
๐ฉ๐ชNuernberg, Germany
Klinikum Kempten Klinik fรผr Innere Medizin III - Hรคmatologie, Onkologie und Palliativmedizin
๐ฉ๐ชKoln, Germany
Klinikum Ludwigshafen
๐ฉ๐ชLudwigshafen, Germany
Universitรคt Heidelberg Medizinische Klinik V Hรคmatologie, Onkologie und Rheumatologie
๐ฉ๐ชHeidelberg, Germany
Rotkreuzklinikum Mรผnchen
๐ฉ๐ชMuenchen, Germany
National & Kapodistrian University of Athens, Attiko University Hospital
๐ฌ๐ทChaidari, Greece
University of Patras Medical School
๐ฌ๐ทPatras, Greece
Somogy Megyei Kaposi Mรณr Oktatรณ Kรณrhรกz
๐ญ๐บKaposvรกr, Hungary
Pรฉcsi Tudomรกnyegyetem, รOK, I. szรกmรบ Belgyรณgyรกszati Klinika
๐ญ๐บPรฉcs, Hungary
Regional Cancer Centre, IGIMS
๐ฎ๐ณPatna, Bihar, India
Rajiv Gandhi Cancer Hospital
๐ฎ๐ณNew Delhi, Delhi, India
Veszprรฉm Megyei Csolnoky Ferenc Kรณrhรกz
๐ญ๐บVeszprรฉm, Hungary
SRM Institutes for Medical Science
๐ฎ๐ณVadapalani, Chennai, India
Institute of Medical Sciences & SUM Hospital
๐ฎ๐ณBhubaneswar, Odisha, India
King George's Medical University (KGMU)
๐ฎ๐ณLucknow, Uttar Pradesh, India
Deenanath Mangeshkar Hospital
๐ฎ๐ณPune, Maharashtra, India
G. Kuppu Swamy Naidu Hospital
๐ฎ๐ณCoimbatore, Tamil Nadu, India
Saveetha Medical College Hospital
๐ฎ๐ณChennai, Tamil Nadu, India
IRCH, All India Institute of Medical Sciences
๐ฎ๐ณDelhi, India
Netaji Subhas Chandra Bose Cancer Research Institute
๐ฎ๐ณKolkata, West Bengal, India
Nil Ratan Sircar Medical College and Hospital
๐ฎ๐ณKolkata, West Bengal, India
Rambam Healthcare Campus
๐ฎ๐ฑHaifa, Israel
Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences
๐ฎ๐ณNew Delhi, India
Wolfson MC
๐ฎ๐ฑHolon, Israel
Hematology-Soroka
๐ฎ๐ฑBeer Sheva, Israel
Hadassah Medical Center
๐ฎ๐ฑJerusalem, Israel
Sheba Medical Center
๐ฎ๐ฑTel Hashomer, Israel
Rabin Medical Center
๐ฎ๐ฑPetach Tikva, Israel
Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna
๐ฎ๐นBologna, Italy
SODc Ematologica ,AOU Careggi
๐ฎ๐นFlorence, Italy
AOU Maggiore della Caritร SCDU Ematologia
๐ฎ๐นFlorence, Italy
Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS
๐ฎ๐นNaples, Italy
SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale
๐ฎ๐นNovara, Italy
Fondazione Policlinico Universitario A. Gemelli
๐ฎ๐นRome, Italy
Azienda Ospedaliero-Universitaria Senese
๐ฎ๐นSiena, Italy
Cittร della Salute e della Scienza di Torino
๐ฎ๐นTorino, Italy
LUMC (leidse universitair medisch centrum)
๐ณ๐ฑLeiden, Netherlands
Christchurch Hospital
๐ณ๐ฟChristchurch, New Zealand
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza
๐ต๐ฑWrocลaw, Radeckiego, Poland
North Shore Hospital
๐ณ๐ฟAuckland, New Zealand
Klinicko Bolnick Centar Zemun Odeljenje hematologije
๐ท๐ธBelgrade, Serbia
Maria Sklodowska Curie National Research Institute
๐ต๐ฑWarszawa, Poland
Centrum Onkologii- Insytut Im. Marii Skลodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego
๐ต๐ฑWarszawa, Poland
Kliniฤki centar Srbije Klinika za hematologiju
๐ท๐ธBelgrade, Serbia
Hospital Universitario de Salamanca
๐ช๐ธSalamanca, Spain
Kliniฤko bolniฤki centar Zvezdara
๐ท๐ธBelgrade, Serbia
Hospital University Vall d'Hebron
๐ช๐ธBarcelona, Spain
Hospitla Universitari Germans Trias i Pujol - ICO
๐ช๐ธBadalona, Spain
Institut za onkologiju Vojvodine
๐ท๐ธSremska Kamenica, Serbia
Hospital de Son Llร tzer
๐ช๐ธPalma de Mallorca, Spain
Hospital Universitario La Paz
๐ช๐ธMadrid, Spain
Leeds Teaching Hospitals NHS Trust
๐ฌ๐งLeeds, Yorkshire, United Kingdom
Clรญnica Universidad De Navarra
๐ช๐ธPamplona, Spain
Royal Marsden Hospital
๐ฌ๐งSutton, London, United Kingdom
Addenbrooke's Hospital Cambridge
๐ฌ๐งCambridge, United Kingdom
Hospital Universitario Virgen del Rocio
๐ช๐ธSevilla, Spain
Northwick Park Hospital
๐ฌ๐งHarrow, Middlesex, United Kingdom
Southampton University Hospital
๐ฌ๐งSouthampton, Hampshire, United Kingdom
King's College Hospital
๐ฌ๐งLondon, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
๐ฌ๐งLiverpool, United Kingdom
Princess Royal University Hospital (PRUH)
๐ฌ๐งLondon, United Kingdom
The Christie NHS Foundation Trust
๐ฌ๐งManchester, United Kingdom
Derriford Hospital
๐ฌ๐งPlymouth, United Kingdom
Norton Cancer Institute
๐บ๐ธLouisville, Kentucky, United States
Medizinische Hochschule
๐ฉ๐ชHannover, Germany
University of California San Francisco
๐บ๐ธSan Francisco, California, United States
Klinikum Leverkusen
๐ฉ๐ชLeverkusen, Germany
Tufts Medical Center
๐บ๐ธBoston, Massachusetts, United States
Icon Cancer Care
๐ฆ๐บSouth Brisbane, Queensland, Australia
Ashford Cancer Centre
๐ฆ๐บKurralta Park, South Australia, Australia
Liverpool Hospital, Ingham Institute of Medical Research
๐ฆ๐บLiverpool, New South Wales, Australia
St. Vincent's Melbourne
๐ฆ๐บFitzroy, Victoria, Australia
Unite Hemopathies Lymphoides Chu Henri Mondor
๐ซ๐ทCrรฉteil, France
Hรดpital Necker Service d'Hรฉmatologie Adult
๐ซ๐ทParis, France
Martin-Luther-University Halle-Wittenberg Department of Oncology
๐ฉ๐ชHalle, Germany
Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)
๐ฉ๐ชBerlin, Germany
Charite Universitatsmedizin Berlin (Virchow Campus)
๐ฉ๐ชBerlin, Germany
Second Depth of Internal Medicine, Attiko University Hospital
๐ฌ๐ทAthens, Greece
TLV Sorasky Medical Center
๐ฎ๐ฑTel Aviv, Israel
Memorial Provincial Specialist Hospital in Lodz
๐ต๐ฑลรณdลบ, Poland
Hospital Clinic i Provincial de Barcelona
๐ช๐ธBarcelona, Spain
Royal Liverpool University Hospital
๐ฌ๐งLiverpool, United Kingdom
Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital
๐ฌ๐งOxford, United Kingdom
TATA Memorial Centre
๐ฎ๐ณKolkata, West Bengal, India
Guy's and St Thomas' NHS Foundation Trust
๐ฌ๐งLondon, United Kingdom