Clinical trial NCT02227251: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse large B-cell Lymphoma
DLBCL
Karyopharm
KPT-330
selinexor
Lead sponsor: Karyopharm Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2014-08-28
Enrollment: 244
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: 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 criteria: Inclusion Criteria (Parts 1 and 2):

* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first screening procedure.
* Age greater than or equal to (≥) 18 years.
* ECOG performance status of less than or equal to (≤) 2.
* Participants should have estimated life expectancy of greater than (\>) 3 months at study entry.
* Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
* Participants must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL including (i) at least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Participants who were considered ineligible for standard multi-agent immunochemotherapy must have received at least 2 and no more than 5 prior treatment regimens including at least 1 course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
* Female participants of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for 3 months after their last dose of medication. Male participants must use a reliable method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose.

Part 1 additional inclusion criteria:

* For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other participants, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered anti DLBCL therapy, and therefore is allowed during the therapy-free interval.
* Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
* Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is \>1.0. Lymph nodes ≤1.0 by ≤1.0 will not be considered abnormal for relapse or PD.

Part 2 additional inclusion criteria:

• At least 3 weeks (21 days) must have elapsed since the end of participant's most recent systemic anti-DLBCL therapy (prior to Cycle 1 Day 1). Palliative localized radiation within the therapy-free interval is allowed.Non-chemotherapy maintenance will not be considered anti-DLBCL therapy, and therefore is allowed during the therapy-free interval.

• Adequate hematopoietic function: (i) Hemoglobin ≥10.0 grams per deciliters (g/dL) within 14 days of starting therapy (participant may receive red blood cell \[RBC\] transfusion within 14 days).

(ii) Absolute neutrophil count ≥1000 cells/millimeter (mm\^3) (use of granulocyte growth factors prior to and during the study is acceptable).

(iii) Platelet count ≥100,000/mm\^3 within 14 days of starting therapy (use of platelet growth factors prior to and during the study is acceptable).

* Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal if the long axis is \>1.0 cm.

Exclusion Criteria (Parts 1 and 2):

* Participants who are pregnant or lactating.
* Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
* Participants must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (Investigator must provide detailed documentation for ineligibility).
* Participants who have not recovered to Grade ≤1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
* Major surgery within 2 weeks of first dose of study treatment.
* Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections.
* Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures.
* Any of the following laboratory abnormalities:

  (i) A circulating lymphocyte count of \>50,000/L. (ii) Hepatic dysfunction: bilirubin \>2.0 times the upper limit of normal (ULN) (except participants with Gilbert's syndrome: total bilirubin of \>3\*ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 times ULN. In participants with known liver involvement of their DLBCL, AST and ALT \>5\*ULN.

(iii) Severe renal dysfunction: estimated creatinine clearance of \<30 mL/min, measured in 24-hour urine or calculated using the formula of Cockroft and Gault \[(140-Age)\*Mass (kg)/(72\*creatinine mg/dL); multiply by 0.85 if female\].

* Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety.
* Participants with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
* Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents is acceptable even if parenteral.
* Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal disease or gastrointestinal dysfunction that could interfere with absorption of study treatment.

Part 1 additional exclusion criteria:

* For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR: Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \<60 days or \<14 weeks prior to Cycle 1 Day 1.
* Known central nervous system lymphoma or meningeal involvement.
* DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, composite lymphoma (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.
* Unstable cardiovascular function:

  (i) Symptomatic ischemia, or (ii) Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or (iii) Congestive heart failure of New York Heart Association Class ≥3, or (iv) Myocardial infarction within 3 months.
* Participants with a BSA \<1.4 m\^2 as calculated per Dubois 1916 or Mosteller 1987.
* Any of the following laboratory abnormalities:

  (i) Absolute neutrophil count (ANC) \<1000 cells/mm\^3 or platelet count \<75,000/mm\^3 during screening and on Cycle 1 Day 1. Use of granulocyte-stimulating factors and platelet growth factors prior to and during the study is acceptable.

(ii) Hematopoietic dysfunction: hemoglobin \< 10.0 g/dL within 14 days of and including Cycle 1 Day 1 and/or patients receiving red blood cell (RBC) transfusion within 14 days of and including Cycle 1 Day 1.

* Participants who have been committed to an institution by official or judicial order.
* Participants with dependency on the Sponsor, Investigator or study site.

Part 2 additional exclusion criteria:

* Participants with active HBV, HVC, or HIV infections. Participants with active HBV are allowed if antiviral therapy for hepatitis B has been given for \>8 weeks and viral load is \<100 International units per milliliters (IU/mL) prior to first dose of study treatment. Participants with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. Participants with HIV who have CD4+T-cell counts ≥350 cells/microliter (mcL), negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year are allowed.
* Known active central nervous system lymphoma or meningeal involvement. Participants with a history of CNS disease treated into remission may be enrolled.
* DLBCL with MALT lymphoma, composite lymphoma (Hodgkin's lymphoma + NHL), DLBCL arising from CLL (Richter's transformation), or high-grade B-cell lymphoma.
* Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or strong CYP3A inducers ≤14 days prior to Day 1 dosing.

Primary outcomes:
measure: Part 1: Overall Response Rate (ORR)
timeFrame: One year
measure: Part 2: Overall Response Rate (ORR) Based on Lugano Criteria
timeFrame: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary outcomes:
measure: Part 1: Duration of Response (DOR)
timeFrame: From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)
measure: Part 1: Disease Control Rate (DCR)
timeFrame: From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)
measure: Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
measure: Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
measure: Part 2: Duration of response (DOR)
timeFrame: From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
measure: Part 2: Disease control rate (DCR)
timeFrame: From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
measure: Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria
timeFrame: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
measure: Part 2: Number of Participants with Treatment-emergent Adverse Events
timeFrame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
measure: Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: UACC Arizona
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles (UCLA)
state: California
city: Plantation
country: United States
facility: Boca Raton Cancer Research Medical Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center/Northwestern University
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Lake Success
country: United States
facility: Clinical Research Alliance
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/ Cornell Medical College
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Hospital & Medical Center
state: Washington
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital, Ingham Institute of Medical Research
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Care
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: East Melbourne
country: Australia
facility: Epworth Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Graz
country: Austria
facility: Medical University of Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck für Innere Medizin
city: Leoben
country: Austria
facility: LKH Leoben Department for Haemato-Oncology
city: Linz
country: Austria
facility: Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie
city: Linz
country: Austria
facility: Krankenhaus Barmherzigen Schwestern Linz
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz GmbH
city: Salzburg
country: Austria
facility: Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg
city: Vienna
country: Austria
facility: Medical University of Vienna (MUW) Department of Medicine I
city: Vienna
country: Austria
facility: Univ. General Hospital Hietzing
city: Antwerpen
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Bruges
country: Belgium
facility: AZ Sint-Jan
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: La Louviere
country: Belgium
facility: CH Jolimont
city: Roeselare
country: Belgium
facility: AZ Delta
city: Roeselare
country: Belgium
facility: H-Hartziekenhuis Roeselare-Menen
city: Pleven
country: Bulgaria
facility: University Hospital for Active Treatment Dr. Georgi Stranski
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Haematological Diseases EAD
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Sir Mortimer B Davis Jewish General Hospital/McGill University
state: Quebec
city: Pierre-Bénite
country: France
facility: CHU Lyon Sud
state: Lyon
city: Créteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Créteil
country: France
facility: Unite Hemopathies Lymphoides Chu Henri Mondor
city: Dijon
country: France
facility: Chu Dijon-Bourgogne - Hematologie Clinique
city: La Rochelle
country: France
facility: Hospitalier de la Rochelle-Ré-Aunis
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude-Huriez
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)
city: Paris
country: France
facility: Hôpital Necker Service d'Hématologie Adult
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Aachen
country: Germany
facility: Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin (Virchow Campus)
city: Bremen
country: Germany
facility: Ev. Diakonie-Krankenhaus gGmbH
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Haematologie and Onkologie-Dresden
city: Halle
country: Germany
facility: Martin-Luther-University Halle-Wittenberg Department of Oncology
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Heidelberg
country: Germany
facility: Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie
city: Koln
country: Germany
facility: Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Muenchen
country: Germany
facility: Rotkreuzklinikum München
city: Nuernberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Exochi
country: Greece
facility: Haematology Department and HCT Unit G.Papanicolaou Hospital
state: Thessaloniki
city: Athens
country: Greece
facility: Hematology Clinic,General Hospital of Athens,G. Gennimatos
city: Athens
country: Greece
facility: National & Kapodistrian University of Athens, Laiko General Hospital
city: Athens
country: Greece
facility: Hematology Department Laiko General Hospital
city: Athens
country: Greece
facility: Second Depth of Internal Medicine, Attiko University Hospital
city: Chaidari
country: Greece
facility: National & Kapodistrian University of Athens, Attiko University Hospital
city: Ioánnina
country: Greece
facility: Department of clinical hematology ,university hospital Ioannina
city: Patras
country: Greece
facility: University of Patras Medical School
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Általános Orvosi Kar
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály
city: Budapest
country: Hungary
facility: Semmelweis University Department of Medicine and Oncology
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika
city: Veszprém
country: Hungary
facility: Veszprém Megyei Csolnoky Ferenc Kórház
city: Veszprém
country: Hungary
facility: CSolnoky ferenc Hospital
city: Patna
country: India
facility: Regional Cancer Centre, IGIMS
state: Bihar
city: Vadapalani
country: India
facility: SRM Institutes for Medical Science
state: Chennai
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Hospital
state: Delhi
city: Thiruvananthapuram
country: India
facility: Regional Cancer Centre
state: Kerala
city: Mumbai
country: India
facility: Prince Aly Khan Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: Institute of Medical Sciences & SUM Hospital
state: Odisha
city: Ludhiāna
country: India
facility: Dayanand Medical College and Hospital
state: Punjab
city: Chennai
country: India
facility: Cancer Institute (WIA)
state: Tamil Nadu
city: Chennai
country: India
facility: Saveetha Medical College Hospital
state: Tamil Nadu
city: Coimbatore
country: India
facility: G. Kuppu Swamy Naidu Hospital
state: Tamil Nadu
city: Madurai
country: India
facility: Meenakshi Mission Hospital & Research Centre
state: Tamil Nadu
city: Lucknow
country: India
facility: King George's Medical University (KGMU)
state: Uttar Pradesh
city: Kolkata
country: India
facility: Nil Ratan Sircar Medical College and Hospital
state: West Bengal
city: Kolkata
country: India
facility: Netaji Subhas Chandra Bose Cancer Research Hospital
state: West Bengal
city: Kolkata
country: India
facility: TATA Memorial Centre
state: West Bengal
city: Kolkata
country: India
facility: Netaji Subhas Chandra Bose Cancer Research Institute
state: West Bengal
city: Delhi
country: India
facility: IRCH, All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences
city: Beer Sheva
country: Israel
facility: Hematology-Soroka
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
city: Holon
country: Israel
facility: Wolfson MC
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Tel Aviv
country: Israel
facility: TLV Sorasky Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Bologna
country: Italy
facility: Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna
city: Florence
country: Italy
facility: SODc Ematologica ,AOU Careggi
city: Florence
country: Italy
facility: AOU Maggiore della Carità SCDU Ematologia
city: Naples
country: Italy
facility: Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS
city: Novara
country: Italy
facility: SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Siena
country: Italy
facility: Azienda Ospedaliero-Universitaria Senese
city: Torino
country: Italy
facility: Città della Salute e della Scienza di Torino
city: Amsterdam
country: Netherlands
facility: VUMc (Vrije Universiteit Amsterdam)
city: Leiden
country: Netherlands
facility: LUMC (leidse universitair medisch centrum)
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza
state: Radeckiego
city: Gdynia
country: Poland
facility: Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii
city: Krakow
country: Poland
facility: MCM (Małopolskie Centrum Medyczne)
city: Legnica
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Legnicy
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
city: Lublin
country: Poland
facility: Hematology Department St John's Cancer Centre
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Warszawa
country: Poland
facility: Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego
city: Warszawa
country: Poland
facility: Maria Sklodowska Curie National Research Institute
city: Łódź
country: Poland
facility: Memorial Provincial Specialist Hospital in Lodz
city: Belgrade
country: Serbia
facility: Institut za onkologiju i radiologiju Srbije
city: Belgrade
country: Serbia
facility: Klinicko Bolnick Centar Zemun Odeljenje hematologije
city: Belgrade
country: Serbia
facility: Klinički centar Srbije Klinika za hematologiju
city: Belgrade
country: Serbia
facility: Kliničko bolnički centar Zvezdara
city: Nis
country: Serbia
facility: Klinički centar Niš Klinika za hematologiju
city: Sremska Kamenica
country: Serbia
facility: Institut za onkologiju Vojvodine
city: Badalona
country: Spain
facility: Hospitla Universitari Germans Trias i Pujol - ICO
city: Barcelona
country: Spain
facility: Hospital University Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Llàtzer
city: Pamplona
country: Spain
facility: Clínica Universidad De Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
state: Gloucestershire
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
state: Hampshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: London
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
state: Middlesex
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: Yorkshire
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital Cambridge
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Princess Royal University Hospital (PRUH)
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
References:
citation: Schuster M, Zijlstra J, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Neste EVD, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Follows G, Egyed M, Offner F, Vassilakopoulos T, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M, Maerevoet M. Effect of Prior Therapy and Disease Refractoriness on the Efficacy and Safety of Oral Selinexor in Patients with Diffuse Large B-cell Lymphoma (DLBCL): A Post-hoc Analysis of the SADAL Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):483-494. doi: 10.1016/j.clml.2021.12.016. Epub 2021 Dec 25.
citation: Maerevoet M, Zijlstra JM, Follows G, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Van Den Neste E, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vassilakopoulos TP, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M. Survival among patients with relapsed/refractory diffuse large B cell lymphoma treated with single-agent selinexor in the SADAL study. J Hematol Oncol. 2021 Jul 16;14(1):111. doi: 10.1186/s13045-021-01122-1.
citation: Shah J, Shacham S, Kauffman M, Daniele P, Tomaras D, Tremblay G, Casasnovas RO, Maerevoet M, Zijlstra J, Follows G, P Vermaat JS, Kalakonda N, Goy AH, Choquet S, Den Neste EV, Hill BT, Thieblemont C, Cavallo F, la Cruz F, Kuruvilla J, Hamad N, Bouabdallah R, Jager U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vasilakopoulos TP, Samal P, Nagy A, Ku M, Canales Albendea MA. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma. Future Oncol. 2021 Apr;17(11):1295-1310. doi: 10.2217/fon-2020-0946. Epub 2021 Feb 2.
citation: Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. doi: 10.1016/S2352-3026(20)30120-4.