501
Participants
Start Date
September 3, 2020
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Selinexor (combination therapy)
Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
Selinexor (combination therapy)
Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
Selinexor (combination therapy)
Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
Placebo matching for Selinexor (combination therapy)
Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
Rituximab (combination therapy)
Dose: 375 milligram per meter square (mg/m\^2) on Day 1; Route of administration: intravenous (IV)
Rituximab (combination therapy)
Dose: 375 mg/m\^2 on Day 1; Route of administration: IV
Gemcitabine (combination therapy)
Dose: 1000 mg/m\^2 on Days 1 and 8; Route of administration: IV
Dexamethasone (combination therapy)
Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV
Cisplatin (combination therapy)
Dose: 75 mg/m\^2 on Day 1; Route of administration: IV
Selinexor (continuous therapy)
Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral
Placebo matching for Selinexor (continuous therapy)
Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral
WITHDRAWN
University of Vienna, Medical Clinic I, Hematology, Vienna
WITHDRAWN
Hospital Hietzing, Vienna
WITHDRAWN
Kepler Universitaetskrankenhaus Med Campu III - Onkologie, Linz
COMPLETED
AOU City of Health and Science of Turin, Turin
RECRUITING
Stony Brook, Stony Brook
RECRUITING
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore
COMPLETED
Hospital Universitario La Paz, Madrid
RECRUITING
AOU Maggiore della Carità SCDU Ematologia, Novara
WITHDRAWN
AOU Policlinico S.Orsola Malpighi di Bologna, University of Bologna, Bologna
RECRUITING
Norton Cancer Institute, St. Matthews, Louisville
COMPLETED
Hospital Virgen del Rocío, Seville
WITHDRAWN
Gabrail Cancer Center Research LLC, Canton
WITHDRAWN
Investigative Clinical Research of Indiana, LLC, Indianapolis
RECRUITING
AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia, Ancona
COMPLETED
CM Pratia Poznań, Skorzewo
COMPLETED
DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi, Pescara
WITHDRAWN
Tulane Cancer Center, New Orleans
WITHDRAWN
Texas Oncology - Plano East, Plano
WITHDRAWN
Texas Oncology - Medical City Dallas, Dallas
WITHDRAWN
Texas Oncology - Presbyterian Dallas Cancer Center, Dallas
WITHDRAWN
Texas Oncology - Sammons, Dallas
RECRUITING
Texas Oncology - Tyler, Tyler
COMPLETED
The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center, Tyler
WITHDRAWN
Texas Oncology - Fort Worth, Fort Worth
RECRUITING
"UOC Ematologia ad Indirizzo Oncologico, AORN Sant'Anna e San Sebastiano", Caserta
COMPLETED
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Chandler
RECRUITING
Arizona Oncology Associates, Tucson
WITHDRAWN
New Mexico Cancer Care Alliance, Albuquerque
WITHDRAWN
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas
RECRUITING
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo
RECRUITING
The Oncology Institute (TOI) Clinical Research, Cerritos
WITHDRAWN
Providence Regional Cancer Partnership, Everett
COMPLETED
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School, Huangpu
COMPLETED
Zhongshan Hospital Fudan University, Xuhui
COMPLETED
Jiangsu Province Hospital, Nanjing
COMPLETED
The First Affiliated Hospital of Soochow University, Suzhou
COMPLETED
The first affiliated Hospital, Zhejiang University, Hangzhou
COMPLETED
Huaxi Hospital Sichuan University, Chengdu
WITHDRAWN
Rambam health care campus (Department of Hematology & Bone Marrow Transplantation), Haifa
COMPLETED
Rabin Medical Center, Petah Tikva
WITHDRAWN
Wolfson Medical Center, Holon
COMPLETED
Assuta medical centers - Ramat Hachayal, Tel Aviv
WITHDRAWN
Sourasky Medical Center, Tel Aviv
RECRUITING
Assuta Ashdod Medical Center, Ashdod
COMPLETED
Soroka Medical Center, Beersheba
WITHDRAWN
Hadassah Medical Center, Jerusalem
RECRUITING
National Cancer Institute, Naples
RECRUITING
Fondatione Policlinico Universitario A. Gemelli, Rome
RECRUITING
Pratia MCM Krakow, Krakow
RECRUITING
Szpitale pomorskie gdynia dept of haematology, Gdynia
COMPLETED
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu, Wroclaw
COMPLETED
Pratia Onkologia Katowice, Katowice
COMPLETED
Institute of Hematology and Transfusion Medicine, Warsaw
COMPLETED
Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw
RECRUITING
Institut català d'oncologia-hospital germans trias i pujol, Badalona
COMPLETED
Hospital Vall Hebron, Barcelona
RECRUITING
Institut Catala D'oncolocia, Barcelona
Lead Sponsor
Karyopharm Therapeutics Inc
INDUSTRY