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

NCT ID: NCT02227251

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Selinexor

Intervention Type DRUG

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

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).

Group Type EXPERIMENTAL

Selinexor

Intervention Type DRUG

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

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).

Group Type EXPERIMENTAL

Selinexor

Intervention Type DRUG

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

Interventions

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Selinexor

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

Intervention Type DRUG

Selinexor

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

Intervention Type DRUG

Selinexor

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

Intervention Type DRUG

Other Intervention Names

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KPT-330 KPT-330 KPT-330

Eligibility Criteria

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Inclusion Criteria

* Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first screening procedure.
* Age greater than or equal to (≥) 18 years.
* ECOG performance status of less than or equal to (≤) 2.
* Participants should have estimated life expectancy of greater than (\>) 3 months at study entry.
* Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
* Participants must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL including (i) at least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Participants who were considered ineligible for standard multi-agent immunochemotherapy must have received at least 2 and no more than 5 prior treatment regimens including at least 1 course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
* Female participants of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for 3 months after their last dose of medication. Male participants must use a reliable method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose.


* For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other participants, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered anti DLBCL therapy, and therefore is allowed during the therapy-free interval.
* Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
* Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is \>1.0. Lymph nodes ≤1.0 by ≤1.0 will not be considered abnormal for relapse or PD.


• At least 3 weeks (21 days) must have elapsed since the end of participant's most recent systemic anti-DLBCL therapy (prior to Cycle 1 Day 1). Palliative localized radiation within the therapy-free interval is allowed.Non-chemotherapy maintenance will not be considered anti-DLBCL therapy, and therefore is allowed during the therapy-free interval.

• Adequate hematopoietic function: (i) Hemoglobin ≥10.0 grams per deciliters (g/dL) within 14 days of starting therapy (participant may receive red blood cell \[RBC\] transfusion within 14 days).

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

(iii) Platelet count ≥100,000/mm\^3 within 14 days of starting therapy (use of platelet growth factors prior to and during the study is acceptable).

* Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal if the long axis is \>1.0 cm.

Exclusion Criteria

* Participants who are pregnant or lactating.
* Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
* Participants must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (Investigator must provide detailed documentation for ineligibility).
* Participants who have not recovered to Grade ≤1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
* Major surgery within 2 weeks of first dose of study treatment.
* Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections.
* Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures.
* Any of the following laboratory abnormalities:

(i) A circulating lymphocyte count of \>50,000/L. (ii) Hepatic dysfunction: bilirubin \>2.0 times the upper limit of normal (ULN) (except participants with Gilbert's syndrome: total bilirubin of \>3\*ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 times ULN. In participants with known liver involvement of their DLBCL, AST and ALT \>5\*ULN.

(iii) Severe renal dysfunction: estimated creatinine clearance of \<30 mL/min, measured in 24-hour urine or calculated using the formula of Cockroft and Gault \[(140-Age)\*Mass (kg)/(72\*creatinine mg/dL); multiply by 0.85 if female\].

* Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety.
* Participants with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
* Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents is acceptable even if parenteral.
* Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal disease or gastrointestinal dysfunction that could interfere with absorption of study treatment.


* For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR: Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \<60 days or \<14 weeks prior to Cycle 1 Day 1.
* 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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karyopharm Therapeutics Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UACC Arizona

Tucson, Arizona, United States

Site Status COMPLETED

University of California San Francisco

San Francisco, California, United States

Site Status COMPLETED

University of California Los Angeles (UCLA)

Santa Monica, California, United States

Site Status COMPLETED

Boca Raton Cancer Research Medical Center

Plantation, Florida, United States

Site Status COMPLETED

University of Chicago

Chicago, Illinois, United States

Site Status COMPLETED

Robert H. Lurie Comprehensive Cancer Center/Northwestern University

Chicago, Illinois, United States

Site Status COMPLETED

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status COMPLETED

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status COMPLETED

Tufts Medical Center

Boston, Massachusetts, United States

Site Status COMPLETED

Lahey Clinic

Burlington, Massachusetts, United States

Site Status COMPLETED

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status COMPLETED

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status COMPLETED

Clinical Research Alliance

Lake Success, New York, United States

Site Status COMPLETED

New York Presbyterian Hospital/ Cornell Medical College

New York, New York, United States

Site Status COMPLETED

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status COMPLETED

Gabrail Cancer Center

Canton, Ohio, United States

Site Status COMPLETED

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status COMPLETED

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Site Status COMPLETED

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status COMPLETED

Greenville Hospital System

Greenville, South Carolina, United States

Site Status COMPLETED

MD Anderson

Houston, Texas, United States

Site Status COMPLETED

Swedish Cancer Institute

Seattle, Washington, United States

Site Status COMPLETED

Virginia Mason Hospital & Medical Center

Seattle, Washington, United States

Site Status COMPLETED

St. Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status COMPLETED

Liverpool Hospital, Ingham Institute of Medical Research

Liverpool, New South Wales, Australia

Site Status COMPLETED

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Site Status COMPLETED

Icon Cancer Care

South Brisbane, Queensland, Australia

Site Status COMPLETED

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status COMPLETED

Ashford Cancer Centre

Kurralta Park, South Australia, Australia

Site Status COMPLETED

Monash Medical Centre

Clayton, Victoria, Australia

Site Status COMPLETED

Epworth Hospital

East Melbourne, Victoria, Australia

Site Status COMPLETED

St. Vincent's Melbourne

Fitzroy, Victoria, Australia

Site Status COMPLETED

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status COMPLETED

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Site Status COMPLETED

Medical University of Graz

Graz, , Austria

Site Status COMPLETED

Medizinische Universität Innsbruck für Innere Medizin

Innsbruck, , Austria

Site Status COMPLETED

LKH Leoben Department for Haemato-Oncology

Leoben, , Austria

Site Status COMPLETED

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

Linz, , Austria

Site Status COMPLETED

Krankenhaus Barmherzigen Schwestern Linz

Linz, , Austria

Site Status COMPLETED

Krankenhaus der Elisabethinen Linz GmbH

Linz, , Austria

Site Status COMPLETED

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

Salzburg, , Austria

Site Status COMPLETED

Medical University of Vienna (MUW) Department of Medicine I

Vienna, , Austria

Site Status COMPLETED

Univ. General Hospital Hietzing

Vienna, , Austria

Site Status COMPLETED

Ziekenhuis Netwerk Antwerpen

Antwerp, , Belgium

Site Status COMPLETED

AZ Sint-Jan

Bruges, , Belgium

Site Status COMPLETED

Institut Jules Bordet

Brussels, , Belgium

Site Status COMPLETED

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status COMPLETED

UZ Gent

Ghent, , Belgium

Site Status COMPLETED

CH Jolimont

La Louvière, , Belgium

Site Status COMPLETED

AZ Delta

Roeselare, , Belgium

Site Status COMPLETED

H-Hartziekenhuis Roeselare-Menen

Roeselare, , Belgium

Site Status COMPLETED

University Hospital for Active Treatment Dr. Georgi Stranski

Pleven, , Bulgaria

Site Status COMPLETED

University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

Sofia, , Bulgaria

Site Status COMPLETED

Specialized Hospital for Active Treatment of Haematological Diseases EAD

Sofia, , Bulgaria

Site Status COMPLETED

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status COMPLETED

Sir Mortimer B Davis Jewish General Hospital/McGill University

Montreal, Quebec, Canada

Site Status COMPLETED

CHU Lyon Sud

Pierre-Bénite, Lyon, France

Site Status COMPLETED

Centre Hospitalier Universitaire Henri Mondor

Créteil, , France

Site Status COMPLETED

Unite Hemopathies Lymphoides Chu Henri Mondor

Créteil, , France

Site Status COMPLETED

Chu Dijon-Bourgogne - Hematologie Clinique

Dijon, , France

Site Status COMPLETED

Hospitalier de la Rochelle-Ré-Aunis

La Rochelle, , France

Site Status COMPLETED

CHRU de Lille - Hopital Claude-Huriez

Lille, , France

Site Status COMPLETED

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

Marseille, , France

Site Status COMPLETED

CHU Montpellier

Montpellier, , France

Site Status COMPLETED

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

Paris, , France

Site Status COMPLETED

Hôpital Necker Service d'Hématologie Adult

Paris, , France

Site Status COMPLETED

Pitié-Salpêtrière Hospital

Paris, , France

Site Status SUSPENDED

Centre Henri Becquerel

Rouen, , France

Site Status SUSPENDED

Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, , Germany

Site Status COMPLETED

HELIOS Klinikum Bad Saarow

Bad Saarow, , Germany

Site Status COMPLETED

Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

Berlin, , Germany

Site Status COMPLETED

Charite Universitatsmedizin Berlin (Virchow Campus)

Berlin, , Germany

Site Status COMPLETED

Ev. Diakonie-Krankenhaus gGmbH

Bremen, , Germany

Site Status COMPLETED

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

Cologne, , Germany

Site Status COMPLETED

Gemeinschaftspraxis Haematologie and Onkologie-Dresden

Dresden, , Germany

Site Status COMPLETED

Martin-Luther-University Halle-Wittenberg Department of Oncology

Halle, , Germany

Site Status COMPLETED

Medizinische Hochschule

Hanover, , Germany

Site Status COMPLETED

Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

Heidelberg, , Germany

Site Status COMPLETED

Klinikum Leverkusen

Leverkusen, , Germany

Site Status COMPLETED

Klinikum Ludwigshafen

Ludwigshafen, , Germany

Site Status COMPLETED

Rotkreuzklinikum München

München, , Germany

Site Status COMPLETED

Klinikum Nürnberg Nord

Nuremberg, , Germany

Site Status COMPLETED

Haematology Department and HCT Unit G.Papanicolaou Hospital

Exochi, Thessaloniki, Greece

Site Status RECRUITING

Hematology Clinic,General Hospital of Athens,G. Gennimatos

Athens, , Greece

Site Status RECRUITING

National & Kapodistrian University of Athens, Laiko General Hospital

Athens, , Greece

Site Status COMPLETED

Hematology Department Laiko General Hospital

Athens, , Greece

Site Status RECRUITING

Second Depth of Internal Medicine, Attiko University Hospital

Athens, , Greece

Site Status RECRUITING

National & Kapodistrian University of Athens, Attiko University Hospital

Chaïdári, , Greece

Site Status COMPLETED

Department of clinical hematology ,university hospital Ioannina

Ioannina, , Greece

Site Status RECRUITING

University of Patras Medical School

Pátrai, , Greece

Site Status COMPLETED

Semmelweis Egyetem Általános Orvosi Kar

Budapest, , Hungary

Site Status COMPLETED

Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

Budapest, , Hungary

Site Status COMPLETED

Semmelweis University Department of Medicine and Oncology

Budapest, , Hungary

Site Status COMPLETED

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, , Hungary

Site Status COMPLETED

Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

Pécs, , Hungary

Site Status COMPLETED

Veszprém Megyei Csolnoky Ferenc Kórház

Veszprém, , Hungary

Site Status COMPLETED

CSolnoky ferenc Hospital

Veszprém, , Hungary

Site Status COMPLETED

Regional Cancer Centre, IGIMS

Patna, Bihar, India

Site Status COMPLETED

SRM Institutes for Medical Science

Vadapalani, Chennai, India

Site Status COMPLETED

IRCH, All India Institute of Medical Sciences

Delhi, India, India

Site Status COMPLETED

Regional Cancer Centre

Thiruvananthapuram, Kerala, India

Site Status COMPLETED

Prince Aly Khan Hospital

Mumbai, Maharashtra, India

Site Status COMPLETED

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

Site Status COMPLETED

Deenanath Mangeshkar Hospital

Pune, Maharashtra, India

Site Status COMPLETED

Rajiv Gandhi Cancer Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status COMPLETED

Institute of Medical Sciences & SUM Hospital

Bhubaneswar, Odisha, India

Site Status COMPLETED

Dayanand Medical College and Hospital

Ludhiana, Punjab, India

Site Status COMPLETED

Cancer Institute (WIA)

Chennai, Tamil Nadu, India

Site Status COMPLETED

Saveetha Medical College Hospital

Chennai, Tamil Nadu, India

Site Status COMPLETED

G. Kuppu Swamy Naidu Hospital

Coimbatore, Tamil Nadu, India

Site Status COMPLETED

Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, India

Site Status COMPLETED

King George's Medical University (KGMU)

Lucknow, Uttar Pradesh, India

Site Status COMPLETED

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, India

Site Status COMPLETED

Netaji Subhas Chandra Bose Cancer Research Hospital

Kolkata, West Bengal, India

Site Status COMPLETED

TATA Memorial Centre

Kolkata, West Bengal, India

Site Status COMPLETED

Netaji Subhas Chandra Bose Cancer Research Institute

Kolkata, West Bengal, India

Site Status COMPLETED

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

New Delhi, , India

Site Status COMPLETED

Hematology-Soroka

Beersheba, , Israel

Site Status COMPLETED

Rambam Healthcare Campus

Haifa, , Israel

Site Status COMPLETED

Wolfson MC

Holon, , Israel

Site Status COMPLETED

Hadassah Medical Center

Jerusalem, , Israel

Site Status COMPLETED

Rabin Medical Center

Petah Tikva, , Israel

Site Status COMPLETED

Assuta Medical Center

Tel Aviv, , Israel

Site Status COMPLETED

TLV Sorasky Medical Center

Tel Aviv, , Israel

Site Status COMPLETED

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status COMPLETED

Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

Bologna, , Italy

Site Status COMPLETED

SODc Ematologica ,AOU Careggi

Florence, , Italy

Site Status RECRUITING

AOU Maggiore della Carità SCDU Ematologia

Florence, , Italy

Site Status RECRUITING

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

Naples, , Italy

Site Status RECRUITING

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

Novara, , Italy

Site Status COMPLETED

Fondazione Policlinico Universitario A. Gemelli

Rome, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Senese

Siena, , Italy

Site Status RECRUITING

Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status COMPLETED

VUMc (Vrije Universiteit Amsterdam)

Amsterdam, , Netherlands

Site Status COMPLETED

LUMC (leidse universitair medisch centrum)

Leiden, , Netherlands

Site Status COMPLETED

North Shore Hospital

Auckland, , New Zealand

Site Status COMPLETED

Christchurch Hospital

Christchurch, , New Zealand

Site Status COMPLETED

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

Wroclaw, Radeckiego, Poland

Site Status RECRUITING

Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

Gdynia, , Poland

Site Status COMPLETED

MCM (Małopolskie Centrum Medyczne)

Krakow, , Poland

Site Status COMPLETED

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, , Poland

Site Status RECRUITING

Memorial Provincial Specialist Hospital in Lodz

Lodz, , Poland

Site Status COMPLETED

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, , Poland

Site Status WITHDRAWN

Hematology Department St John's Cancer Centre

Lublin, , Poland

Site Status COMPLETED

Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

Olsztyn, , Poland

Site Status COMPLETED

Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

Site Status COMPLETED

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

Warsaw, , Poland

Site Status COMPLETED

Maria Sklodowska Curie National Research Institute

Warsaw, , Poland

Site Status RECRUITING

Institut za onkologiju i radiologiju Srbije

Belgrade, , Serbia

Site Status COMPLETED

Klinicko Bolnick Centar Zemun Odeljenje hematologije

Belgrade, , Serbia

Site Status COMPLETED

Klinički centar Srbije Klinika za hematologiju

Belgrade, , Serbia

Site Status COMPLETED

Kliničko bolnički centar Zvezdara

Belgrade, , Serbia

Site Status COMPLETED

Institut za onkologiju Vojvodine

Kamenitz, , Serbia

Site Status COMPLETED

Klinički centar Niš Klinika za hematologiju

Niš, , Serbia

Site Status COMPLETED

Hospitla Universitari Germans Trias i Pujol - ICO

Badalona, , Spain

Site Status COMPLETED

Hospital University Vall d'Hebron

Barcelona, , Spain

Site Status COMPLETED

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status COMPLETED

Hospital Universitario La Paz

Madrid, , Spain

Site Status COMPLETED

Hospital de Son Llàtzer

Palma de Mallorca, , Spain

Site Status COMPLETED

Clínica Universidad De Navarra

Pamplona, , Spain

Site Status COMPLETED

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status COMPLETED

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status COMPLETED

Gloucestershire Royal Hospital

Gloucester, Gloucestershire, United Kingdom

Site Status COMPLETED

Southampton University Hospital

Southampton, Hampshire, United Kingdom

Site Status COMPLETED

Royal Marsden Hospital

Sutton, London, United Kingdom

Site Status COMPLETED

Northwick Park Hospital

Harrow, Middlesex, United Kingdom

Site Status COMPLETED

Leeds Teaching Hospitals NHS Trust

Leeds, Yorkshire, United Kingdom

Site Status COMPLETED

Addenbrooke's Hospital Cambridge

Cambridge, , United Kingdom

Site Status COMPLETED

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status COMPLETED

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, , United Kingdom

Site Status COMPLETED

King's College Hospital

London, , United Kingdom

Site Status COMPLETED

Princess Royal University Hospital (PRUH)

London, , United Kingdom

Site Status COMPLETED

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status COMPLETED

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status COMPLETED

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

Oxford, , United Kingdom

Site Status COMPLETED

Derriford Hospital

Plymouth, , United Kingdom

Site Status COMPLETED

Countries

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United States Australia Austria Belgium Bulgaria Canada France Germany Greece Hungary India Israel Italy Netherlands New Zealand Poland Serbia Spain United Kingdom

Central Contacts

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Karyopharm Medical Information

Role: CONTACT

(888) 209-9326

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Niki Stavroyianni

Role: primary

+302313307533

Theodoros Marinakis

Role: primary

00306932704780

Theodoros Vassilakopoulos

Role: primary

+30 6945472338

Panagiotis Tsirigotis

Role: primary

+306944618814

Eleni Kapsali

Role: primary

0032651099650

Luca Nassi

Role: primary

00390557947358

Clara Deambrogi (SC)

Role: primary

003903213732094

Antonio Pinto

Role: primary

+39 (0) 81 5903 1816

Stefan Hohaus

Role: primary

+39-0630154180

ALBERTO FABBRI

Role: primary

+390577585618

Tomasz Wrobel

Role: primary

+48 533 193 182

Jadwiga Holojda

Role: primary

+48 767211621

Joanna Romejko-Jarosinska

Role: primary

48225462448

References

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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.

Reference Type DERIVED
PMID: 35078739 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34271963 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33528286 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32589977 (View on PubMed)

Other Identifiers

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2014-001977-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KCP-330-009

Identifier Type: -

Identifier Source: org_study_id

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