AzTrials
AzTrials

Diffuse Large B-cell LymphomaPhase 2NCT02227251

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A Phase 2 study testing Selinexor in people with Diffuse Large B-cell Lymphoma, run by Karyopharm Therapeutics Inc at 175 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Selinexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
175 sitesin 19 countries
Study dates
Nov 2014to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
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  • 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:
  • 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.
  • 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:
  • 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:
  • 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.
  • 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.

Trial locations and contacts

175 sites in 19 countries.

175 sites in 19 countries

United States23 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts

  • Tufts Medical Center

    Boston, Massachusetts

  • Lahey Clinic

    Burlington, Massachusetts

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • University of Chicago

    Chicago, Illinois, 60637

  • Robert H. Lurie Comprehensive Cancer Center/Northwestern University

    Chicago, Illinois

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey

  • MD Anderson

    Houston, Texas, 77030

  • Clinical Research Alliance

    Lake Success, New York

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • New York Presbyterian Hospital/ Cornell Medical College

    New York, New York, 10065

  • University of Oklahoma

    Oklahoma City, Oklahoma

  • Boca Raton Cancer Research Medical Center

    Plantation, Florida

  • University of California San Francisco

    San Francisco, California

  • University of California Los Angeles (UCLA)

    Santa Monica, California, 90404

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Virginia Mason Hospital & Medical Center

    Seattle, Washington

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • UACC Arizona

    Tucson, Arizona, 85704

  • University of Massachusetts Medical School

    Worcester, Massachusetts

Other trials in United States

India20 sites

  • Institute of Medical Sciences & SUM Hospital

    Bhubaneswar, Odisha, 751003

  • Cancer Institute (WIA)

    Chennai, Tamil Nadu, 600020

  • Saveetha Medical College Hospital

    Chennai, Tamil Nadu, 602105

  • G. Kuppu Swamy Naidu Hospital

    Coimbatore, Tamil Nadu, 641037

  • IRCH, All India Institute of Medical Sciences

    Delhi, India, 110029

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata, West Bengal, 700014

  • Netaji Subhas Chandra Bose Cancer Research Hospital

    Kolkata, West Bengal, 700094

  • TATA Memorial Centre

    Kolkata, West Bengal, 700156

  • Netaji Subhas Chandra Bose Cancer Research Institute

    Kolkata, West Bengal, 70016

  • King George's Medical University (KGMU)

    Lucknow, Uttar Pradesh, 226003

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 160012

  • Meenakshi Mission Hospital & Research Centre

    Madurai, Tamil Nadu, 625107

  • Prince Aly Khan Hospital

    Mumbai, Maharashtra, 400010

  • Jaslok Hospital and Research Centre

    Mumbai, Maharashtra, 400026

  • Rajiv Gandhi Cancer Hospital

    New Delhi, National Capital Territory of Delhi, 110085

  • Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences

    New Delhi, 110029

  • Regional Cancer Centre, IGIMS

    Patna, Bihar, 800014

  • Deenanath Mangeshkar Hospital

    Pune, Maharashtra, 411004

  • Regional Cancer Centre

    Thiruvananthapuram, Kerala, 695011

  • SRM Institutes for Medical Science

    Vadapalani, Chennai, 600026

Other trials in India

Germany14 sites

  • Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

    Aachen

  • HELIOS Klinikum Bad Saarow

    Bad Saarow

  • Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

    Berlin

  • Charite Universitatsmedizin Berlin (Virchow Campus)

    Berlin

  • Ev. Diakonie-Krankenhaus gGmbH

    Bremen, 28239

  • Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin

    Cologne

  • Gemeinschaftspraxis Haematologie and Onkologie-Dresden

    Dresden, 01307

  • Martin-Luther-University Halle-Wittenberg Department of Oncology

    Halle

  • Medizinische Hochschule

    Hanover

  • Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

    Heidelberg

  • Klinikum Leverkusen

    Leverkusen

  • Klinikum Ludwigshafen

    Ludwigshafen

  • Rotkreuzklinikum München

    München

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

Other trials in Germany

United Kingdom14 sites

  • Addenbrooke's Hospital Cambridge

    Cambridge, CB2 0QQ

  • Gloucestershire Royal Hospital

    Gloucester, Gloucestershire, GL1 3NN

  • Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ

  • Leeds Teaching Hospitals NHS Trust

    Leeds, Yorkshire

  • Royal Liverpool University Hospital

    Liverpool

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool

  • King's College Hospital

    London, SE5 9RS

  • Princess Royal University Hospital (PRUH)

    London, SE5 9RS

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital

    Oxford, OX3 7LE

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Southampton University Hospital

    Southampton, Hampshire, SO16 6YD

  • Royal Marsden Hospital

    Sutton, London, SM2 5PT

Other trials in United Kingdom

France12 sites

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil

  • Unite Hemopathies Lymphoides Chu Henri Mondor

    Créteil

  • Chu Dijon-Bourgogne - Hematologie Clinique

    Dijon

  • Hospitalier de la Rochelle-Ré-Aunis

    La Rochelle

  • CHRU de Lille - Hopital Claude-Huriez

    Lille

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille

  • CHU Montpellier

    Montpellier

  • Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)

    Paris, 75010

  • Hôpital Necker Service d'Hématologie Adult

    Paris

  • Pitié-Salpêtrière Hospital

    Paris

  • CHU Lyon Sud

    Pierre-Bénite, Lyon

  • Centre Henri Becquerel

    Rouen

Other trials in France

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Epworth Hospital

    East Melbourne, Victoria, 3001

  • St. Vincent's Melbourne

    Fitzroy, Victoria, 3065

  • Ashford Cancer Centre

    Kurralta Park, South Australia, 5037

  • Liverpool Hospital, Ingham Institute of Medical Research

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Icon Cancer Care

    South Brisbane, Queensland, 4101

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

Other trials in Australia

Poland10 sites

  • Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

    Gdynia, 81-519

  • MCM (Małopolskie Centrum Medyczne)

    Krakow, 30-510

  • Wojewodzki Szpital Specjalistyczny w Legnicy

    Legnica, 59-220

  • Memorial Provincial Specialist Hospital in Lodz

    Lodz, 62-1010

  • Hematology Department St John's Cancer Centre

    Lublin

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

    Olsztyn, 10-228

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781

  • Maria Sklodowska Curie National Research Institute

    Warsaw

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

    Wroclaw, Radeckiego, 50-367

Other trials in Poland

Austria9 sites

  • Medical University of Graz

    Graz, 8036

  • Medizinische Universität Innsbruck für Innere Medizin

    Innsbruck

  • LKH Leoben Department for Haemato-Oncology

    Leoben, 8700

  • Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie

    Linz

  • Krankenhaus Barmherzigen Schwestern Linz

    Linz

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz

  • Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg

    Salzburg, A-5020

  • Medical University of Vienna (MUW) Department of Medicine I

    Vienna

  • Univ. General Hospital Hietzing

    Vienna

Other trials in Austria

Belgium8 sites

  • Ziekenhuis Netwerk Antwerpen

    Antwerp

  • AZ Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels

  • UZ Gent

    Ghent, 9000

  • CH Jolimont

    La Louvière, 7100

  • AZ Delta

    Roeselare

  • H-Hartziekenhuis Roeselare-Menen

    Roeselare

Other trials in Belgium

Greece8 sites

  • Hematology Clinic,General Hospital of Athens,G. Gennimatos

    Athens, 11527

  • National & Kapodistrian University of Athens, Laiko General Hospital

    Athens, 11527

  • Hematology Department Laiko General Hospital

    Athens

  • Second Depth of Internal Medicine, Attiko University Hospital

    Athens

  • National & Kapodistrian University of Athens, Attiko University Hospital

    Chaïdári, 12462

  • Haematology Department and HCT Unit G.Papanicolaou Hospital

    Exochi, Thessaloniki

  • Department of clinical hematology ,university hospital Ioannina

    Ioannina, 45110

  • University of Patras Medical School

    Pátrai, 26504

Other trials in Greece

Israel8 sites

  • Soroka University Medical Center

    Beersheba

  • Rambam Healthcare Campus

    Haifa

  • Wolfson MC

    Holon

  • Hadassah Medical Center

    Jerusalem

  • Rabin Medical Center

    Petah Tikva, 49100

  • Assuta Medical Center

    Tel Aviv, 69710

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

  • Sheba Medical Center

    Tel HaShomer

Other trials in Israel

Italy8 sites

  • Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

    Bologna

  • SODc Ematologica ,AOU Careggi

    Florence, 50134

  • AOU Maggiore della Carità SCDU Ematologia

    Florence

  • Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS

    Naples, 80131

  • SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale

    Novara, 28100

  • Fondazione Policlinico Universitario A. Gemelli

    Rome

  • Azienda Ospedaliero-Universitaria Senese

    Siena

  • Città della Salute e della Scienza di Torino

    Torino

Other trials in Italy

Spain8 sites

  • Hospitla Universitari Germans Trias i Pujol - ICO

    Badalona, 8916

  • Hospital University Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona

  • Hospital Universitario La Paz

    Madrid

  • Hospital de Son Llàtzer

    Palma de Mallorca

  • Clínica Universidad De Navarra

    Pamplona

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville

Other trials in Spain

Hungary7 sites

  • Semmelweis Egyetem Általános Orvosi Kar

    Budapest, 1083

  • Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

    Budapest, 1122

  • Semmelweis University Department of Medicine and Oncology

    Budapest

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

    Pécs

  • Veszprém Megyei Csolnoky Ferenc Kórház

    Veszprém, 8200

  • CSolnoky ferenc Hospital

    Veszprém

Other trials in Hungary

Serbia6 sites

  • Institut za onkologiju i radiologiju Srbije

    Belgrade, 11000

  • Klinicko Bolnick Centar Zemun Odeljenje hematologije

    Belgrade, 11000

  • Klinički centar Srbije Klinika za hematologiju

    Belgrade, 11000

  • Kliničko bolnički centar Zvezdara

    Belgrade, 11000

  • Institut za onkologiju Vojvodine

    Kamenitz, 21204

  • Klinički centar Niš Klinika za hematologiju

    Niš, 18000

Other trials in Serbia

Bulgaria3 sites

  • University Hospital for Active Treatment Dr. Georgi Stranski

    Pleven, 5800

  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

    Sofia, 1431

  • Specialized Hospital for Active Treatment of Haematological Diseases EAD

    Sofia, 1756

Other trials in Bulgaria

Canada2 sites

  • Sir Mortimer B Davis Jewish General Hospital/McGill University

    Montreal, Quebec

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

Netherlands2 sites

  • VUMc (Vrije Universiteit Amsterdam)

    Amsterdam, 1081 HV

  • LUMC (leidse universitair medisch centrum)

    Leiden

Other trials in Netherlands

New Zealand2 sites

  • North Shore Hospital

    Auckland, 0622

  • Christchurch Hospital

    Christchurch, 8001

Other trials in New Zealand

About this study

Official title: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

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.

Read the 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.

Being tested
Selinexor
Keywords
Diffuse large B-cell Lymphoma, DLBCL, Karyopharm, KPT-330, selinexor
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Also called KPT-330

    Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

  • SelinexorDrug

    Also called KPT-330

    Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

  • SelinexorDrug

    Also called KPT-330

    Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral

Study groups in NCT02227251
Study groupRoleWhat they receive
Part 1: Selinexor 60 mgExperimentalParticipants 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).
Receives: Drug: Selinexor
Part 2: Arm A-Selinexor 40 mgExperimentalParticipants 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).
Receives: Drug: Selinexor
Part 2: Arm B-Selinexor 60 mgExperimentalParticipants 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).
Receives: Drug: Selinexor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Overall Response Rate (ORR)

    Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).

    Measured: One year

  2. Part 2: Overall Response Rate (ORR) Based on Lugano Criteria

    Assessed according to the response assessment of lymphoma based on Lugano classification.

    Measured: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)

Secondary outcomes (9)

  1. Part 1: Duration of Response (DOR)

    Measured: From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)

  2. Part 1: Disease Control Rate (DCR)

    Measured: From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)

  3. Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)

  4. Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status

    Measured: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)

  5. Part 2: Duration of response (DOR)

    Measured: From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)

  6. Part 2: Disease control rate (DCR)

    Measured: From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)

  7. Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria

    Measured: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)

  8. Part 2: Number of Participants with Treatment-emergent Adverse Events

    Measured: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)

  9. Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status

    Measured: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227251
Sponsor's protocol ID
KCP-330-009
Other IDs
2014-001977-15, 2014
Status last verified
Sep 2026
First submitted
12 Aug 2014
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35078739

  • 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.

    PubMed 34271963

  • 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.

    PubMed 33528286

  • 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.

    PubMed 32589977

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor in people with Diffuse Large B-cell Lymphoma, run by Karyopharm Therapeutics Inc at 175 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, India, Germany, United Kingdom, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Overall Response Rate (ORR) (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02227251, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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