Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
2 other identifiers
interventional
244
18 countries
166
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2014
Longer than P75 for phase_2
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 6, 2026
May 1, 2026
12.1 years
August 12, 2014
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1: Overall Response Rate (ORR)
Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).
One year
Part 2: Overall Response Rate (ORR) Based on Lugano Criteria
Assessed according to the response assessment of lymphoma based on Lugano classification.
From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Secondary Outcomes (9)
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 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 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)
- +4 more secondary outcomes
Study Arms (3)
Part 1: Selinexor 60 mg
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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).
Interventions
Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
UACC Arizona
Tucson, Arizona, 85704, United States
University of California San Francisco
San Francisco, California, United States
University of California Los Angeles (UCLA)
Santa Monica, California, 90404, United States
Boca Raton Cancer Research Medical Center
Plantation, Florida, United States
University of Chicago
Chicago, Illinois, 60637, United States
Robert H. Lurie Comprehensive Cancer Center/Northwestern University
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, 40241, 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, 10065, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, 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, 29605, United States
MD Anderson
Houston, Texas, 77030, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Virginia Mason Hospital & Medical Center
Seattle, Washington, United States
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Liverpool Hospital, Ingham Institute of Medical Research
Liverpool, New South Wales, 2170, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Icon Cancer Care
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Ashford Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Epworth Hospital
East Melbourne, Victoria, 3001, Australia
St. Vincent's Melbourne
Fitzroy, Victoria, 3065, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medical University of Graz
Graz, 8036, Austria
Medizinische Universität Innsbruck für Innere Medizin
Innsbruck, Austria
LKH Leoben Department for Haemato-Oncology
Leoben, 8700, Austria
Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie
Linz, Austria
Krankenhaus Barmherzigen Schwestern Linz
Linz, Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria
Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg
Salzburg, A-5020, Austria
Medical University of Vienna (MUW) Department of Medicine I
Vienna, Austria
Univ. General Hospital Hietzing
Vienna, Austria
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Gent
Ghent, 9000, Belgium
CH Jolimont
La Louvière, 7100, Belgium
AZ Delta
Roeselare, Belgium
H-Hartziekenhuis Roeselare-Menen
Roeselare, Belgium
University Hospital for Active Treatment Dr. Georgi Stranski
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases EAD
Sofia, 1756, Bulgaria
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital/McGill University
Montreal, Quebec, Canada
CHU Lyon Sud
Pierre-Bénite, 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-Ré-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, 75010, France
Hôpital Necker Service d'Hématologie Adult
Paris, France
Pitié-Salpêtrière Hospital
Paris, France
Centre Henri Becquerel
Rouen, France
Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie 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, 28239, Germany
Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin
Cologne, Germany
Gemeinschaftspraxis Haematologie and Onkologie-Dresden
Dresden, 01307, Germany
Martin-Luther-University Halle-Wittenberg Department of Oncology
Halle, Germany
Medizinische Hochschule
Hanover, Germany
Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie
Heidelberg, Germany
Klinikum Leverkusen
Leverkusen, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Rotkreuzklinikum München
München, Germany
Klinikum Nürnberg Nord
Nuremberg, 90419, Germany
Haematology Department and HCT Unit G.Papanicolaou Hospital
Exochi, Thessaloniki, Greece
Hematology Clinic,General Hospital of Athens,G. Gennimatos
Athens, 11527, Greece
National & Kapodistrian University of Athens, Laiko General Hospital
Athens, 11527, 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
Chaïdári, 12462, Greece
Department of clinical hematology ,university hospital Ioannina
Ioannina, 45110, Greece
University of Patras Medical School
Pátrai, 26504, Greece
Semmelweis Egyetem Általános Orvosi Kar
Budapest, 1083, Hungary
Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály
Budapest, 1122, Hungary
Semmelweis University Department of Medicine and Oncology
Budapest, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika
Pécs, Hungary
Veszprém Megyei Csolnoky Ferenc Kórház
Veszprém, 8200, Hungary
CSolnoky ferenc Hospital
Veszprém, Hungary
Regional Cancer Centre, IGIMS
Patna, Bihar, 800014, India
SRM Institutes for Medical Science
Vadapalani, Chennai, 600026, India
IRCH, All India Institute of Medical Sciences
Delhi, India, 110029, India
Regional Cancer Centre
Thiruvananthapuram, Kerala, 695011, India
Prince Aly Khan Hospital
Mumbai, Maharashtra, 400010, India
Jaslok Hospital and Research Centre
Mumbai, Maharashtra, 400026, India
Deenanath Mangeshkar Hospital
Pune, Maharashtra, 411004, India
Rajiv Gandhi Cancer Hospital
New Delhi, National Capital Territory of Delhi, 110085, India
Institute of Medical Sciences & SUM Hospital
Bhubaneswar, Odisha, 751003, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, 160012, India
Cancer Institute (WIA)
Chennai, Tamil Nadu, 600020, India
Saveetha Medical College Hospital
Chennai, Tamil Nadu, 602105, India
G. Kuppu Swamy Naidu Hospital
Coimbatore, Tamil Nadu, 641037, India
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, 625107, India
King George's Medical University (KGMU)
Lucknow, Uttar Pradesh, 226003, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014, India
Netaji Subhas Chandra Bose Cancer Research Hospital
Kolkata, West Bengal, 700094, India
TATA Memorial Centre
Kolkata, West Bengal, 700156, India
Netaji Subhas Chandra Bose Cancer Research Institute
Kolkata, West Bengal, 70016, India
Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences
New Delhi, 110029, India
Hematology-Soroka
Beersheba, Israel
Rambam Healthcare Campus
Haifa, Israel
Wolfson MC
Holon, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Assuta Medical Center
Tel Aviv, 69710, Israel
TLV Sorasky Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna
Bologna, Italy
SODc Ematologica ,AOU Careggi
Florence, 50134, Italy
AOU Maggiore della Carità SCDU Ematologia
Florence, Italy
Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS
Naples, 80131, Italy
SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale
Novara, 28100, Italy
Fondazione Policlinico Universitario A. Gemelli
Rome, Italy
Azienda Ospedaliero-Universitaria Senese
Siena, Italy
Città della Salute e della Scienza di Torino
Torino, Italy
VUMc (Vrije Universiteit Amsterdam)
Amsterdam, 1081 HV, Netherlands
LUMC (leidse universitair medisch centrum)
Leiden, Netherlands
North Shore Hospital
Auckland, 0622, New Zealand
Christchurch Hospital
Christchurch, 8001, New Zealand
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza
Wroclaw, Radeckiego, 50-367, Poland
Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii
Gdynia, 81-519, Poland
MCM (Małopolskie Centrum Medyczne)
Krakow, 30-510, Poland
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica, 59-220, Poland
Memorial Provincial Specialist Hospital in Lodz
Lodz, 62-1010, Poland
Hematology Department St John's Cancer Centre
Lublin, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa
Olsztyn, 10-228, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776, Poland
Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego
Warsaw, 02-781, Poland
Maria Sklodowska Curie National Research Institute
Warsaw, Poland
Institut za onkologiju i radiologiju Srbije
Belgrade, 11000, Serbia
Klinicko Bolnick Centar Zemun Odeljenje hematologije
Belgrade, 11000, Serbia
Klinički centar Srbije Klinika za hematologiju
Belgrade, 11000, Serbia
Kliničko bolnički centar Zvezdara
Belgrade, 11000, Serbia
Institut za onkologiju Vojvodine
Kamenitz, 21204, Serbia
Klinički centar Niš Klinika za hematologiju
Niš, 18000, Serbia
Hospitla Universitari Germans Trias i Pujol - ICO
Badalona, 8916, Spain
Hospital University Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital de Son Llàtzer
Palma de Mallorca, Spain
Clínica Universidad De Navarra
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Southampton University Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Royal Marsden Hospital
Sutton, London, SM2 5PT, United Kingdom
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, United Kingdom
Addenbrooke's Hospital Cambridge
Cambridge, CB2 0QQ, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Princess Royal University Hospital (PRUH)
London, SE5 9RS, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital
Oxford, OX3 7LE, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Related Publications (4)
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.
PMID: 35078739DERIVEDMaerevoet 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.
PMID: 34271963DERIVEDShah 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.
PMID: 33528286DERIVEDKalakonda 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.
PMID: 32589977DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 28, 2014
Study Start
November 1, 2014
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05