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

June 30, 2026 updated by: Karyopharm Therapeutics Inc

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital, Ingham Institute of Medical Research
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • ICON Cancer Care
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • East Melbourne, Victoria, Australia, 3001
        • Epworth Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Melbourne
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz
      • Innsbruck, Austria
        • Medizinische Universität Innsbruck für Innere Medizin
      • Leoben, Austria, 8700
        • LKH Leoben Department for Haemato-Oncology
      • Linz, 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
      • Salzburg, Austria, A-5020
        • Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg
      • Vienna, Austria
        • Medical University of Vienna (MUW) Department of Medicine I
      • Vienna, Austria
        • Univ. General Hospital Hietzing
  • Belgium
      • Antwerp, Belgium
        • Ziekenhuis Netwerk Antwerpen
      • Bruges, Belgium, 8000
        • AZ Sint-Jan
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Ghent, Belgium, 9000
        • Uz Gent
      • La Louvière, Belgium, 7100
        • CH Jolimont
      • Roeselare, Belgium
        • AZ Delta
      • Roeselare, Belgium
        • H-Hartziekenhuis Roeselare-Menen
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • University Hospital for Active Treatment Dr. Georgi Stranski
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
      • Sofia, Bulgaria, 1756
        • Specialized Hospital for Active Treatment of Haematological Diseases EAD
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Sir Mortimer B Davis Jewish General Hospital/McGill University
  • France
      • Créteil, France
        • Centre Hospitalier Universitaire Henri Mondor
      • Créteil, France
        • Unite Hemopathies Lymphoides Chu Henri Mondor
      • Dijon, France
        • Chu Dijon-Bourgogne - Hematologie Clinique
      • La Rochelle, France
        • Hospitalier de la Rochelle-Ré-Aunis
      • Lille, France
        • CHRU de Lille - Hopital Claude-Huriez
      • Marseille, France
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Montpellier, France
        • CHU Montpellier
      • Paris, France
        • Pitié-Salpêtrière Hospital
      • Paris, France, 75010
        • Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)
      • Paris, France
        • Hôpital Necker Service d'Hématologie Adult
      • Rouen, France
        • Centre Henri Becquerel
    • Lyon
      • Pierre-Bénite, Lyon, France
        • CHU Lyon Sud
  • Germany
      • Aachen, Germany
        • Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
      • Bad Saarow, Germany
        • Helios Klinikum Bad Saarow
      • Berlin, Germany
        • Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)
      • Berlin, Germany
        • Charite Universitatsmedizin Berlin (Virchow Campus)
      • Bremen, Germany, 28239
        • Ev. Diakonie-Krankenhaus gGmbH
      • Cologne, Germany
        • Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis Haematologie and Onkologie-Dresden
      • Halle, Germany
        • Martin-Luther-University Halle-Wittenberg Department of Oncology
      • Hanover, Germany
        • Medizinische Hochschule
      • Heidelberg, Germany
        • Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie
      • Leverkusen, Germany
        • Klinikum Leverkusen
      • Ludwigshafen, Germany
        • Klinikum Ludwigshafen
      • München, Germany
        • Rotkreuzklinikum München
      • Nuremberg, Germany, 90419
        • Klinikum Nürnberg Nord
  • Greece
      • Athens, Greece, 11527
        • Hematology Clinic,General Hospital of Athens,G. Gennimatos
      • Athens, Greece, 11527
        • National & Kapodistrian University of Athens, Laiko General Hospital
      • Athens, Greece
        • Hematology Department Laiko General Hospital
      • Athens, Greece
        • Second Depth of Internal Medicine, Attiko University Hospital
      • Chaïdári, Greece, 12462
        • National & Kapodistrian University of Athens, Attiko University Hospital
      • Ioannina, Greece, 45110
        • Department of clinical hematology ,university hospital Ioannina
      • Pátrai, Greece, 26504
        • University of Patras Medical School
    • Thessaloniki
      • Exochi, Thessaloniki, Greece
        • Haematology Department and HCT Unit G.Papanicolaou Hospital
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem Általános Orvosi Kar
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály
      • Budapest, Hungary
        • Semmelweis University Department of Medicine and Oncology
      • Kaposvár, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
      • Pécs, Hungary
        • Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika
      • Veszprém, Hungary, 8200
        • Veszprém Megyei Csolnoky Ferenc Kórház
      • Veszprém, Hungary
        • CSolnoky ferenc Hospital
  • India
      • New Delhi, India, 110029
        • Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences
    • Bihar
      • Patna, Bihar, India, 800014
        • Regional Cancer Centre, IGIMS
    • Chennai
      • Vadapalani, Chennai, India, 600026
        • SRM Institutes for Medical Science
    • India
      • Delhi, India, India, 110029
        • IRCH, All India Institute of Medical Sciences
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695011
        • Regional Cancer Centre
    • Maharashtra
      • Mumbai, Maharashtra, India, 400026
        • Jaslok Hospital and Research Centre
      • Mumbai, Maharashtra, India, 400010
        • Prince Aly Khan Hospital
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Rajiv Gandhi Cancer Hospital
    • Odisha
      • Bhubaneswar, Odisha, India, 751003
        • Institute of Medical Sciences & SUM Hospital
    • Punjab
      • Ludhiana, Punjab, India, 160012
        • Dayanand Medical College and Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 602105
        • Saveetha Medical College Hospital
      • Chennai, Tamil Nadu, India, 600020
        • Cancer Institute (WIA)
      • Coimbatore, Tamil Nadu, India, 641037
        • G. Kuppu Swamy Naidu Hospital
      • Madurai, Tamil Nadu, India, 625107
        • Meenakshi Mission Hospital & Research Centre
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • King George's Medical University (KGMU)
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • Nil Ratan Sircar Medical College and Hospital
      • Kolkata, West Bengal, India, 700094
        • Netaji Subhas Chandra Bose Cancer Research Hospital
      • Kolkata, West Bengal, India, 700156
        • Tata Memorial Centre
      • Kolkata, West Bengal, India, 70016
        • Netaji Subhas chandra Bose Cancer Research Institute
  • Israel
      • Beersheba, Israel
        • Hematology-Soroka
      • Haifa, Israel
        • Rambam healthcare campus
      • Holon, Israel
        • Wolfson MC
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Tel Aviv, Israel, 69710
        • Assuta Medical Center
      • Tel Aviv, Israel
        • TLV Sorasky Medical Center
      • Tel Litwinsky, Israel
        • Sheba Medical Center
  • Italy
      • Bologna, Italy
        • Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna
      • Florence, Italy, 50134
        • SODc Ematologica ,AOU Careggi
      • Florence, Italy
        • AOU Maggiore della Carità SCDU Ematologia
      • Naples, Italy, 80131
        • Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS
      • Novara, Italy, 28100
        • SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale
      • Rome, Italy
        • Fondazione Policlinico Universitario A. Gemelli
      • Siena, Italy
        • Azienda ospedaliero-universitaria Senese
      • Torino, Italy
        • Citta della Salute e della Scienza di Torino
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VUMc (Vrije Universiteit Amsterdam)
      • Leiden, Netherlands
        • LUMC (leidse universitair medisch centrum)
  • New Zealand
      • Auckland, New Zealand, 0622
        • North Shore Hospital
      • Christchurch, New Zealand, 8001
        • Christchurch Hospital
  • Poland
      • Gdynia, Poland, 81-519
        • Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii
      • Krakow, Poland, 30-510
        • MCM (Małopolskie Centrum Medyczne)
      • Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny w Legnicy
      • Lodz, Poland, 62-1010
        • Memorial Provincial Specialist Hospital in Lodz
      • Lublin, Poland
        • Hematology Department St John's Cancer Centre
      • Olsztyn, Poland, 10-228
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa
      • Warsaw, Poland, 02-776
        • Instytut Hematologii I Transfuzjologii
      • Warsaw, Poland, 02-781
        • Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego
      • Warsaw, Poland
        • Maria Sklodowska Curie National Research Institute
    • Radeckiego
      • Wroclaw, Radeckiego, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza
  • Serbia
      • Belgrade, Serbia, 11000
        • Kliničko bolnički centar Zvezdara
      • Belgrade, Serbia, 11000
        • Institut za onkologiju i radiologiju Srbije
      • Belgrade, Serbia, 11000
        • Klinicko Bolnick Centar Zemun Odeljenje hematologije
      • Belgrade, Serbia, 11000
        • Klinički centar Srbije Klinika za hematologiju
      • Kamenitz, Serbia, 21204
        • Institut za onkologiju Vojvodine
      • Niš, Serbia, 18000
        • Klinički centar Niš Klinika za hematologiju
  • Spain
      • Badalona, Spain, 8916
        • Hospitla Universitari Germans Trias i Pujol - ICO
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Hospital University Vall d'Hebron
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Palma de Mallorca, Spain
        • Hospital de Son Llàtzer
      • Pamplona, Spain
        • Clinica Universidad de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital Cambridge
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • Liverpool, United Kingdom
        • The Clatterbridge Cancer Centre NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • Princess Royal University Hospital (PRUH)
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton University Hospital
    • London
      • Sutton, London, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
    • Yorkshire
      • Leeds, Yorkshire, United Kingdom
        • Leeds Teaching Hospitals NHS Trust
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • UACC Arizona
    • California
      • San Francisco, California, United States
        • University of California San Francisco
      • Santa Monica, California, United States, 90404
        • University of California Los Angeles (UCLA)
    • Florida
      • Plantation, Florida, United States
        • Boca Raton Cancer Research Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States
        • Robert H. Lurie Comprehensive Cancer Center/Northwestern University
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States
        • Tufts Medical Center
      • Burlington, Massachusetts, United States
        • Lahey Clinic
      • Worcester, Massachusetts, United States
        • University of Massachusetts Medical School
    • New Jersey
      • Hackensack, New Jersey, United States
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New York
      • Lake Success, New York, United States
        • Clinical Research Alliance
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital/ Cornell Medical College
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States
        • University Hospitals Seidman Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • University of Oklahoma
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States
        • Virginia Mason Hospital & Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Selinexor 60 mg
Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle).
Drug: Selinexor
Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Drug: Selinexor
Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Drug: Selinexor
Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Experimental: Part 2: Arm A-Selinexor 40 mg
Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle).
Drug: Selinexor
Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Drug: Selinexor
Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Drug: Selinexor
Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Experimental: Part 2: Arm B-Selinexor 60 mg
Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).
Drug: Selinexor
Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Drug: Selinexor
Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330
Drug: Selinexor
Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
Other Names:
  • KPT-330

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Overall Response Rate (ORR)
Time Frame: One year
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
Time Frame: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Assessed according to the response assessment of lymphoma based on Lugano classification.
From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1: Duration of Response (DOR)
Time Frame: From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)
From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)
Part 1: Disease Control Rate (DCR)
Time Frame: From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)
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)
Time Frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
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
Time Frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
Part 2: Duration of response (DOR)
Time Frame: From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
Part 2: Disease control rate (DCR)
Time Frame: From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria
Time Frame: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Part 2: Number of Participants with Treatment-emergent Adverse Events
Time Frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karyopharm Therapeutics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimated)

August 28, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCP-330-009
  • 2014-001977-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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