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RECRUITING

NCT02227251

PHASE2

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

Sponsor: Karyopharm Therapeutics Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2014-11

Completion Date

2027-11

Last Updated

2025-10-01

Healthy Volunteers

Conditions

Diffuse Large B-cell Lymphoma

Interventions

DRUG

Selinexor

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

DRUG

Selinexor

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

DRUG

Selinexor

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

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.

Locations (176)

UACC Arizona

Tucson, Arizona, United States

University of California San Francisco

San Francisco, California, United States

University of California Los Angeles (UCLA)

Santa Monica, California, United States

Boca Raton Cancer Research Medical Center

Plantation, Florida, United States

University of Chicago

Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center/Northwestern University

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Tufts Medical Center

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Clinical Research Alliance

Lake Success, New York, United States

New York Presbyterian Hospital/ Cornell Medical College

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Gabrail Cancer Center

Canton, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Greenville Hospital System

Greenville, South Carolina, United States

MD Anderson

Houston, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Virginia Mason Hospital & Medical Center

Seattle, Washington, United States

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Liverpool Hospital, Ingham Institute of Medical Research

Liverpool, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Icon Cancer Care

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Ashford Cancer Centre

Kurralta Park, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Epworth Hospital

East Melbourne, Victoria, Australia

St. Vincent's Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medical University of Graz

Graz, Austria

Medizinische Universität Innsbruck für Innere Medizin

Innsbruck, Austria

LKH Leoben Department for Haemato-Oncology

Leoben, Austria

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

Linz, Austria

Krankenhaus Barmherzigen Schwestern Linz

Linz, Austria

Krankenhaus der Elisabethinen Linz GmbH

Linz, Austria

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

Salzburg, Austria

Medical University of Vienna (MUW) Department of Medicine I

Vienna, Austria

Univ. General Hospital Hietzing

Vienna, Austria

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

AZ Sint-Jan

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

CH Jolimont

La Louvière, Belgium

AZ Delta

Roeselare, Belgium

H-Hartziekenhuis Roeselare-Menen

Roeselare, Belgium

University Hospital for Active Treatment Dr. Georgi Stranski

Pleven, Bulgaria

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, Bulgaria

Specialized Hospital for Active Treatment of Haematological Diseases EAD

Sofia, Bulgaria

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B Davis Jewish General Hospital/McGill University

Montreal, Quebec, Canada

CHU Lyon Sud

Pierre-Bénite, Lyon, France

Centre Hospitalier Universitaire Henri Mondor

Créteil, France

Unite Hemopathies Lymphoides Chu Henri Mondor

Créteil, France

Chu Dijon-Bourgogne - Hematologie Clinique

Dijon, France

Hospitalier de la Rochelle-Ré-Aunis

La Rochelle, France

CHRU de Lille - Hopital Claude-Huriez

Lille, France

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

Marseille, France

CHU Montpellier

Montpellier, France

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

Paris, France

Hôpital Necker Service d'Hématologie Adult

Paris, France

Pitié-Salpêtrière Hospital

Paris, France

Centre Henri Becquerel

Rouen, France

Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, Germany

HELIOS Klinikum Bad Saarow

Bad Saarow, Germany

Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

Berlin, Germany

Charite Universitatsmedizin Berlin (Virchow Campus)

Berlin, Germany

Ev. Diakonie-Krankenhaus gGmbH

Bremen, Germany

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

Cologne, Germany

Gemeinschaftspraxis Haematologie and Onkologie-Dresden

Dresden, Germany

Martin-Luther-University Halle-Wittenberg Department of Oncology

Halle, Germany

Medizinische Hochschule

Hanover, Germany

Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

Heidelberg, Germany

Klinikum Leverkusen

Leverkusen, Germany

Klinikum Ludwigshafen

Ludwigshafen, Germany

Rotkreuzklinikum München

München, Germany

Klinikum Nürnberg Nord

Nuremberg, Germany

Haematology Department and HCT Unit G.Papanicolaou Hospital

Exochi, Thessaloniki, Greece

Hematology Clinic,General Hospital of Athens,G. Gennimatos

Athens, Greece

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

Athens, Greece

National & Kapodistrian University of Athens, Attiko University Hospital

Chaïdári, Greece

Department of clinical hematology ,university hospital Ioannina

Ioannina, Greece

University of Patras Medical School

Pátrai, Greece

Semmelweis Egyetem Általános Orvosi Kar

Budapest, Hungary

Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

Budapest, Hungary

Semmelweis University Department of Medicine and Oncology

Budapest, Hungary

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Hungary

Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

Pécs, Hungary

Veszprém Megyei Csolnoky Ferenc Kórház

Veszprém, Hungary

CSolnoky ferenc Hospital

Veszprém, Hungary

Regional Cancer Centre, IGIMS

Patna, Bihar, India

SRM Institutes for Medical Science

Vadapalani, Chennai, India

IRCH, All India Institute of Medical Sciences

Delhi, India, India

Regional Cancer Centre

Thiruvananthapuram, Kerala, India

Prince Aly Khan Hospital

Mumbai, Maharashtra, India

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

Deenanath Mangeshkar Hospital

Pune, Maharashtra, India

Rajiv Gandhi Cancer Hospital

New Delhi, National Capital Territory of Delhi, India

Institute of Medical Sciences & SUM Hospital

Bhubaneswar, Odisha, India

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

Cancer Institute (WIA)

Chennai, Tamil Nadu, India

Saveetha Medical College Hospital

Chennai, Tamil Nadu, India

G. Kuppu Swamy Naidu Hospital

Coimbatore, Tamil Nadu, India

Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, India

King George's Medical University (KGMU)

Lucknow, Uttar Pradesh, India

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, India

Netaji Subhas Chandra Bose Cancer Research Hospital

Kolkata, West Bengal, India

TATA Memorial Centre

Kolkata, West Bengal, India

Netaji Subhas Chandra Bose Cancer Research Institute

Kolkata, West Bengal, India

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

New Delhi, India

Hematology-Soroka

Beersheba, Israel

Rambam Healthcare Campus

Haifa, Israel

Wolfson MC

Holon, Israel

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Assuta Medical Center

Tel Aviv, Israel

TLV Sorasky Medical Center

Tel Aviv, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

Bologna, Italy

SODc Ematologica ,AOU Careggi

Florence, Italy

AOU Maggiore della Carità SCDU Ematologia

Florence, Italy

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

Naples, Italy

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

Novara, Italy

Fondazione Policlinico Universitario A. Gemelli

Rome, Italy

Azienda Ospedaliero-Universitaria Senese

Siena, Italy

Città della Salute e della Scienza di Torino

Torino, Italy

VUMc (Vrije Universiteit Amsterdam)

Amsterdam, Netherlands

LUMC (leidse universitair medisch centrum)

Leiden, Netherlands

North Shore Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

Wroclaw, Radeckiego, Poland

Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

Gdynia, Poland

MCM (Małopolskie Centrum Medyczne)

Krakow, Poland

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, Poland

Memorial Provincial Specialist Hospital in Lodz

Lodz, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, Poland

Hematology Department St John's Cancer Centre

Lublin, Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

Olsztyn, Poland

Instytut Hematologii i Transfuzjologii

Warsaw, Poland

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

Warsaw, Poland

Maria Sklodowska Curie National Research Institute

Warsaw, Poland

Institut za onkologiju i radiologiju Srbije

Belgrade, Serbia

Klinicko Bolnick Centar Zemun Odeljenje hematologije

Belgrade, Serbia

Klinički centar Srbije Klinika za hematologiju

Belgrade, Serbia

Kliničko bolnički centar Zvezdara

Belgrade, Serbia

Institut za onkologiju Vojvodine

Kamenitz, Serbia

Klinički centar Niš Klinika za hematologiju

Niš, Serbia

Hospitla Universitari Germans Trias i Pujol - ICO

Badalona, Spain

Hospital University Vall d'Hebron

Barcelona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital de Son Llàtzer

Palma de Mallorca, Spain

Clínica Universidad De Navarra

Pamplona, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Gloucestershire Royal Hospital

Gloucester, Gloucestershire, United Kingdom

Southampton University Hospital

Southampton, Hampshire, United Kingdom

Royal Marsden Hospital

Sutton, London, United Kingdom

Northwick Park Hospital

Harrow, Middlesex, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom

Addenbrooke's Hospital Cambridge

Cambridge, United Kingdom

Royal Liverpool University Hospital

Liverpool, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

King's College Hospital

London, United Kingdom

Princess Royal University Hospital (PRUH)

London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

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

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (176)