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A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Sponsor: Karyopharm Therapeutics Inc
Summary
The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram \[mg\] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.
Official title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
501
Start Date
2020-09-03
Completion Date
2025-12
Last Updated
2025-10-03
Healthy Volunteers
No
Interventions
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
Locations (57)
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Arizona Oncology Associates
Tucson, Arizona, United States
The Oncology Institute (TOI) Clinical Research
Cerritos, California, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States
Norton Cancer Institute, St. Matthews
Louisville, Kentucky, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Stony Brook
Stony Brook, New York, United States
Gabrail Cancer Center Research LLC
Canton, Ohio, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Presbyterian Dallas Cancer Center
Dallas, Texas, United States
Texas Oncology - Sammons
Dallas, Texas, United States
Texas Oncology - Fort Worth
Fort Worth, Texas, United States
Texas Oncology - Plano East
Plano, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Kepler Universitaetskrankenhaus Med Campu III - Onkologie
Linz, Austria, Austria
University of Vienna, Medical Clinic I, Hematology
Vienna, Austria, Austria
Hospital Hietzing
Vienna, Austria, Austria
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Huangpu, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Xuhui, Shanghai Municipality, China
Huaxi Hospital Sichuan University
Chengdu, Sichuan, China
The first affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Assuta Ashdod Medical Center
Ashdod, Israel
Soroka Medical Center
Beersheba, Israel
Rambam health care campus (Department of Hematology & Bone Marrow Transplantation)
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Hadassah Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Assuta medical centers - Ramat Hachayal
Tel Aviv, Israel
Sourasky Medical Center
Tel Aviv, Israel
AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia
Ancona, Ancona, Italy
AOU Policlinico S.Orsola Malpighi di Bologna, University of Bologna
Bologna, Bologna, Italy
UOC Ematologia ad Indirizzo Oncologico, AORN "Sant'Anna e San Sebastiano"
Caserta, Caserta, Italy
National Cancer Institute
Naples, Napoli, Italy
AOU Maggiore della Carità SCDU Ematologia
Novara, Novara, Italy
DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi
Pescara, Pescara, Italy
Fondatione Policlinico Universitario A. Gemelli
Rome, Rome, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Sicily, Italy
AOU City of Health and Science of Turin
Turin, Torino, Italy
Pratia MCM Krakow
Krakow, Lesser, Poland
Szpitale pomorskie gdynia dept of haematology
Gdynia, Pomeranian Voivodeship, Poland
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu
Wroclaw, Radeckiego, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland
CM Pratia Poznań
Skorzewo, Wielkopolska, Poland
Institute of Hematology and Transfusion Medicine
Warsaw, Poland
Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Institut català d'oncologia-hospital germans trias i pujol
Badalona, Barcelona, Spain
Hospital Vall Hebron
Barcelona, Barcelona, Spain
Institut Catala D'oncolocia
Barcelona, Barcelona, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Virgen del Rocío
Seville, Seville, Spain