New hope for lymphoma patients with no other options

NCT ID NCT02227251

Disease control Sponsor: Karyopharm Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests an experimental drug called selinexor in adults with diffuse large B-cell lymphoma that has come back or stopped responding to treatment. The goal is to see if the drug can shrink tumors or control the disease. Participants must have no other proven treatment options available.

Why investors are watching

Karyopharm is testing selinexor, its lead drug, in patients with relapsed or refractory diffuse large B-cell lymphoma who have run out of standard options. For a micro-cap company with few products, this phase 2b readout could determine whether the drug has a future in a common blood cancer.

If it works: If selinexor shows meaningful disease control in these hard-to-treat patients, Karyopharm could advance the drug toward registration and expand its commercial potential beyond its current uses.

If it fails: Phase 2 trials often fail to meet their goals, and a negative or delayed result could set the program back and hurt the company's prospects, since it has limited other sources of value.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

Contacts and locations

Locations

AOU Maggiore della Carità SCDU Ematologia

Florence, Italy
AZ Delta

Roeselare, Belgium
AZ Sint-Jan

Bruges, 8000, Belgium
Addenbrooke's Hospital Cambridge

Cambridge, CB2 0QQ, United Kingdom
Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie

Linz, Austria
Ashford Cancer Centre

Kurralta Park, South Australia, 5037, Australia
Assuta Medical Center

Tel Aviv, 69710, Israel
Azienda Ospedaliero-Universitaria Senese

Siena, Italy
Boca Raton Cancer Research Medical Center

Plantation, Florida, United States
CH Jolimont

La Louvière, 7100, Belgium
CHRU de Lille - Hopital Claude-Huriez

Lille, France
CHU Lyon Sud

Pierre-Bénite, Lyon, France
CHU Montpellier

Montpellier, France
CSolnoky ferenc Hospital

Veszprém, Hungary
Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia
Cancer Institute (WIA)

Chennai, Tamil Nadu, 600020, India
Centre Henri Becquerel

Rouen, France
Centre Hospitalier Universitaire Henri Mondor

Créteil, France
Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego

Warsaw, 02-781, Poland
Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

Berlin, Germany
Charite Universitatsmedizin Berlin (Virchow Campus)

Berlin, Germany
Christchurch Hospital

Christchurch, 8001, New Zealand
Chu Dijon-Bourgogne - Hematologie Clinique

Dijon, France
Città della Salute e della Scienza di Torino

Torino, Italy
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Clinical Research Alliance

Lake Success, New York, United States
Cliniques Universitaires Saint-Luc

Brussels, Belgium
Clínica Universidad De Navarra

Pamplona, Spain
Dana Farber Cancer Institute

Boston, Massachusetts, United States
Dayanand Medical College and Hospital

Ludhiana, Punjab, 160012, India
Deenanath Mangeshkar Hospital

Pune, Maharashtra, 411004, India
Department of clinical hematology ,university hospital Ioannina

Ioannina, 45110, Greece
Derriford Hospital

Plymouth, PL6 8DH, United Kingdom
Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences

New Delhi, 110029, India
Epworth Hospital

East Melbourne, Victoria, 3001, Australia
Ev. Diakonie-Krankenhaus gGmbH

Bremen, 28239, Germany
Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia
Fondazione Policlinico Universitario A. Gemelli

Rome, Italy
G. Kuppu Swamy Naidu Hospital

Coimbatore, Tamil Nadu, 641037, India
Gabrail Cancer Center

Canton, Ohio, 44718, United States
Gemeinschaftspraxis Haematologie and Onkologie-Dresden

Dresden, 01307, Germany
Gloucestershire Royal Hospital

Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Greenville Hospital System

Greenville, South Carolina, 29605, United States
Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom
H-Hartziekenhuis Roeselare-Menen

Roeselare, Belgium
HELIOS Klinikum Bad Saarow

Bad Saarow, Germany
Hadassah Medical Center

Jerusalem, Israel
Haematology Department and HCT Unit G.Papanicolaou Hospital

Exochi, Thessaloniki, Greece
Hematology Clinic,General Hospital of Athens,G. Gennimatos

Athens, 11527, Greece
Hematology Department Laiko General Hospital

Athens, Greece
Hematology Department St John's Cancer Centre

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

Naples, 80131, Italy
Hematology-Soroka

Beersheba, Israel
Hospital Clinic i Provincial de Barcelona

Barcelona, Spain
Hospital Universitario La Paz

Madrid, Spain
Hospital Universitario Virgen del Rocio

Seville, Spain
Hospital Universitario de Salamanca

Salamanca, 37007, Spain
Hospital University Vall d'Hebron

Barcelona, 08035, Spain
Hospital de Son Llàtzer

Palma de Mallorca, Spain
Hospitalier de la Rochelle-Ré-Aunis

La Rochelle, France
Hospitla Universitari Germans Trias i Pujol - ICO

Badalona, 8916, Spain
Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)

Paris, 75010, France
Hôpital Necker Service d'Hématologie Adult

Paris, France
IRCH, All India Institute of Medical Sciences

Delhi, India, 110029, India
Icon Cancer Care

South Brisbane, Queensland, 4101, Australia
Institut Jules Bordet

Brussels, 1000, Belgium
Institut za onkologiju Vojvodine

Kamenitz, 21204, Serbia
Institut za onkologiju i radiologiju Srbije

Belgrade, 11000, Serbia
Institute of Medical Sciences & SUM Hospital

Bhubaneswar, Odisha, 751003, India
Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

Bologna, Italy
Instytut Hematologii i Transfuzjologii

Warsaw, 02-776, Poland
Jaslok Hospital and Research Centre

Mumbai, Maharashtra, 400026, India
John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States
King George's Medical University (KGMU)

Lucknow, Uttar Pradesh, 226003, India
King's College Hospital

London, SE5 9RS, United Kingdom
Klinicko Bolnick Centar Zemun Odeljenje hematologije

Belgrade, 11000, Serbia
Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin

Cologne, Germany
Klinikum Leverkusen

Leverkusen, Germany
Klinikum Ludwigshafen

Ludwigshafen, Germany
Klinikum Nürnberg Nord

Nuremberg, 90419, Germany
Klinički centar Niš Klinika za hematologiju

Niš, 18000, Serbia
Klinički centar Srbije Klinika za hematologiju

Belgrade, 11000, Serbia
Kliničko bolnički centar Zvezdara

Belgrade, 11000, Serbia
Krankenhaus Barmherzigen Schwestern Linz

Linz, Austria
Krankenhaus der Elisabethinen Linz GmbH

Linz, Austria
LKH Leoben Department for Haemato-Oncology

Leoben, 8700, Austria
LUMC (leidse universitair medisch centrum)

Leiden, Netherlands
Lahey Clinic

Burlington, Massachusetts, United States
Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom
Liverpool Hospital, Ingham Institute of Medical Research

Liverpool, New South Wales, 2170, Australia
MCM (Małopolskie Centrum Medyczne)

Krakow, 30-510, Poland
MD Anderson

Houston, Texas, 77030, United States
Maria Sklodowska Curie National Research Institute

Warsaw, Poland
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, France
Martin-Luther-University Halle-Wittenberg Department of Oncology

Halle, Germany
Medical University of Graz

Graz, 8036, Austria
Medical University of Vienna (MUW) Department of Medicine I

Vienna, Austria
Medizinische Hochschule

Hanover, Germany
Medizinische Universität Innsbruck für Innere Medizin

Innsbruck, Austria
Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, 625107, India
Memorial Provincial Specialist Hospital in Lodz

Lodz, 62-1010, Poland
Monash Medical Centre

Clayton, Victoria, 3168, Australia
National & Kapodistrian University of Athens, Attiko University Hospital

Chaïdári, 12462, Greece
National & Kapodistrian University of Athens, Laiko General Hospital

Athens, 11527, Greece
Netaji Subhas Chandra Bose Cancer Research Hospital

Kolkata, West Bengal, 700094, India
Netaji Subhas Chandra Bose Cancer Research Institute

Kolkata, West Bengal, 70016, India
New York Presbyterian Hospital/ Cornell Medical College

New York, New York, 10065, United States
Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India
North Shore Hospital

Auckland, 0622, New Zealand
Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom
Norton Cancer Institute

Louisville, Kentucky, 40241, United States
Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

Budapest, 1122, Hungary
Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital

Oxford, OX3 7LE, United Kingdom
Pitié-Salpêtrière Hospital

Paris, France
Prince Aly Khan Hospital

Mumbai, Maharashtra, 400010, India
Princess Margaret Cancer Centre

Toronto, Ontario, Canada
Princess Royal University Hospital (PRUH)

London, SE5 9RS, United Kingdom
Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

Pécs, Hungary
Rabin Medical Center

Petah Tikva, 49100, Israel
Rajiv Gandhi Cancer Hospital

New Delhi, National Capital Territory of Delhi, 110085, India
Rambam Healthcare Campus

Haifa, Israel
Regional Cancer Centre

Thiruvananthapuram, Kerala, 695011, India
Regional Cancer Centre, IGIMS

Patna, Bihar, 800014, India
Robert H. Lurie Comprehensive Cancer Center/Northwestern University

Chicago, Illinois, United States
Rotkreuzklinikum München

München, Germany
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
Royal Liverpool University Hospital

Liverpool, United Kingdom
Royal Marsden Hospital

Sutton, London, SM2 5PT, United Kingdom
SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale

Novara, 28100, Italy
SODc Ematologica ,AOU Careggi

Florence, 50134, Italy
SRM Institutes for Medical Science

Vadapalani, Chennai, 600026, India
Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

Olsztyn, 10-228, Poland
Saveetha Medical College Hospital

Chennai, Tamil Nadu, 602105, India
Second Depth of Internal Medicine, Attiko University Hospital

Athens, Greece
Semmelweis Egyetem Általános Orvosi Kar

Budapest, 1083, Hungary
Semmelweis University Department of Medicine and Oncology

Budapest, Hungary
Sheba Medical Center

Tel Litwinsky, Israel
Sir Mortimer B Davis Jewish General Hospital/McGill University

Montreal, Quebec, Canada
Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary
Southampton University Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom
Specialized Hospital for Active Treatment of Haematological Diseases EAD

Sofia, 1756, Bulgaria
St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia
St. Vincent's Melbourne

Fitzroy, Victoria, 3065, Australia
Stony Brook University Hospital

Stony Brook, New York, 11794, United States
Swedish Cancer Institute

Seattle, Washington, 98104, United States
Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

Gdynia, 81-519, Poland
TATA Memorial Centre

Kolkata, West Bengal, 700156, India
TLV Sorasky Medical Center

Tel Aviv, Israel
The Alfred Hospital

Melbourne, Victoria, 3004, Australia
The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom
Tufts Medical Center

Boston, Massachusetts, United States
UACC Arizona

Tucson, Arizona, 85704, United States
UZ Gent

Ghent, 9000, Belgium
Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg

Salzburg, A-5020, Austria
Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, Germany
Unite Hemopathies Lymphoides Chu Henri Mondor

Créteil, France
Univ. General Hospital Hietzing

Vienna, Austria
University Hospital for Active Treatment Dr. Georgi Stranski

Pleven, 5800, Bulgaria
University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, 1431, Bulgaria
University of California Los Angeles (UCLA)

Santa Monica, California, 90404, United States
University of California San Francisco

San Francisco, California, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Massachusetts Medical School

Worcester, Massachusetts, United States
University of Oklahoma

Oklahoma City, Oklahoma, United States
University of Patras Medical School

Pátrai, 26504, Greece
Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

Heidelberg, Germany
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

Wroclaw, Radeckiego, 50-367, Poland
VUMc (Vrije Universiteit Amsterdam)

Amsterdam, 1081 HV, Netherlands
Veszprém Megyei Csolnoky Ferenc Kórház

Veszprém, 8200, Hungary
Virginia Mason Hospital & Medical Center

Seattle, Washington, United States
Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, 59-220, Poland
Wolfson MC

Holon, Israel
Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

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