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RECRUITING
NCT04442022
PHASE2/PHASE3

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

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

Rituximab (combination therapy)

Dose: 375 milligram per meter square (mg/m\^2) on Day 1; Route of administration: intravenous (IV)

DRUG

Rituximab (combination therapy)

Dose: 375 mg/m\^2 on Day 1; Route of administration: IV

DRUG

Gemcitabine (combination therapy)

Dose: 1000 mg/m\^2 on Days 1 and 8; Route of administration: IV

DRUG

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

DRUG

Cisplatin (combination therapy)

Dose: 75 mg/m\^2 on Day 1; Route of administration: IV

DRUG

Selinexor (continuous therapy)

Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral

DRUG

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