Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
Cisplatin (combination therapy)
Placebo matching for Selinexor (combination therapy)
Selinexor (combination therapy)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have pathologically confirmed de novo DLBCL or DLBCL transformed from previouslydiagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-gradelymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).
Have received at least 1 but no more than 3 prior lines of systemic therapy for thetreatment of DLBCL with relapsed or refractory disease following their most recentregimen.
Salvage chemoimmunotherapy followed by stem cell transplantation will beconsidered as 1 line of systemic therapy.
Maintenance therapy will not be counted as a separate line of systemic therapy.
Radiation with curative intent for localized DLBCL will not be counted as 1line of systemic therapy.
Positron emission tomography (PET) positive measurable disease with at least 1 nodehaving the longest diameter (LDi) greater than (>) 1.5 centimeter (cm) or 1extranodal lesion with LDi >1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.
Not intended for HSCT or CAR-T cell therapy based on objective clinical criteriadetermined by the treating physician. Patients who cannot receive HSCT due to activedisease are allowed on study (up to approximately 15 percent [%] of patientsenrolled in each Phase). Documentation on lack of intention to proceed to receiveHSCT or CAR-T therapy must be provided by the treating physician.
Adequate bone marrow function at screening, defined as:
Absolute neutrophil count (ANC) ≥1*10^9 per liter (/L).
Platelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 daysprior to Cycle 1 Day 1 [C1D1]).
Hemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion <14 days prior to C1D1).
Circulating lymphocytes less than or equal to (≤) 50*10^9/L.
Adequate liver and kidney function, defined as:
Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5upper limit ofnormal (ULN), or ≤5ULN in cases with known lymphoma involvement in the liver.
Serum total bilirubin ≤2ULN, or ≤5ULN if due to Gilbert syndrome or in caseswith known lymphoma involvement in the liver.
Calculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) basedon Cockcroft-Gault formula.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
An estimated life expectancy of >3 months at Screening.
Patients with primary refractory DLBCL defined as no response or relapse within 6months after ending first-line treatment, will be allowed in the study.
Agree to highly effective contraception during the duration of the study withcontraception use continuing for 12 months after the last dose of study treatment
Female patients of childbearing potential must have a negative serum pregnancy testat Screening and agree to use highly effective methods of contraception throughoutthe study and for 12 months following the last dose of study treatment (exceptpatients with Non-Childbearing potential: Age >50 years and naturally amenorrhoeicfor >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).
Male patients who are sexually active must use highly effective methods ofcontraception throughout the study and for 12 months following the last dose ofstudy treatment. Male patients must agree not to donate sperm during the studytreatment period and for 12 months following the last dose of study treatment.
Exclusion
Exclusion Criteria:
DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseasesother than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL);T-cell rich large B-cell lymphoma.
Previous treatment with selinexor or other XPO1 inhibitors.
Contraindication to any drug contained in the combination therapy regimen (SR-GDP).
Known active central nervous system or meningeal involvement by DLBCL at time ofScreening.
Use of any standard or experimental anti-DLBCL therapy (including nonpalliativeradiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancertherapy) <21 days prior to C1D1 (prednisone <30 mg or equivalent is permitted;palliative radiation is permitted only if on non-target lesions).
Any AE, by C1D1, which has not recovered to Grade ≤1 (Common Terminology Criteriafor Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previousDLBCL therapy, except hematological abnormalities (as specified in the inclusioncriteria) and alopecia.
Major surgery <14 days of Cycle 1 Day 1.
Hematopoietic stem cell transplantation/CAR-T therapy as follows:
Autologous stem cell transplant (SCT) <100 days or allogeneic-SCT <180 daysprior to C1D1
Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannotdiscontinue GVHD treatment or prophylaxis)
CAR-T cell infusion <90 days prior to Cycle 1
Neuropathy Grade ≥2 (CTCAE, v.5.0).
Any life-threatening illness, medical condition, or organ system dysfunction which,in the Investigator's opinion, could compromise the patient's safety, or beingcompliant with the study procedures.
Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics,antivirals, or antifungals within 7 days prior to first dose of study treatment;however, prophylactic use of these agents is acceptable (including parenteral).
Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV) infections:
Patient with active HBV are allowed if antiviral therapy for hepatitis B hasbeen given for >8 weeks and viral load is <100 International units (IU)/mLprior to first dose of study treatment.
Patients with known history of HCV or found to be HCV antibody positive onscreening, are allowed if there is documentation of negative viral load perinstitutional standard.
Patients with HIV are allowed if they have a negative viral load perinstitutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year.
Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment.
Breastfeeding or pregnant women.
Inability or unwillingness to sign an informed consent form (ICF).
In the opinion of the Investigator, patient who are significantly below their idealbody weight.
Patients who received a live attenuated vaccine within prior 28 days of the firstdose of study treatment.
Study Design
Connect with a study center
St. Vincent's Health Network, Kinghorn Cancer Centre
Sydney, New South Wales 2010
AustraliaSite Not Available
Eastern Health
Box Hill, Victoria 3128
AustraliaSite Not Available
St Vincent's Hospital
Melbourne, Victoria 3065
AustraliaSite Not Available
Kepler Universitaetskrankenhaus Med Campu III - Onkologie
Linz 2772400, Austria 4021
AustriaSite Not Available
Hospital Hietzing
Vienna 2761369, Austria 1130
AustriaSite Not Available
University of Vienna, Medical Clinic I, Hematology
Vienna 2761369, Austria 1090
AustriaSite Not Available
Kepler Universitaetskrankenhaus Med Campu III - Onkologie
Linz, 4021
AustriaSite Not Available
Hospital Hietzing
Vienna, 1130
AustriaSite Not Available
University of Vienna, Medical Clinic I, Hematology
Vienna, 1090
AustriaSite Not Available
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing 1799962, Jiangsu 1806260 210029
ChinaCompleted
The First Affiliated Hospital of Soochow University
Suzhou 1886760, Jiangsu 1806260 215006
ChinaCompleted
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Huangpu, Shanghai 200025
ChinaSite Not Available
Zhongshan Hospital Fudan University
Xuhui District, Shanghai 200032
ChinaSite Not Available
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Huangpu 8307452, Shanghai Municipality 1796231 200025
ChinaCompleted
Zhongshan Hospital Fudan University
Xuhui 1787957, Shanghai Municipality 1796231 200032
ChinaCompleted
Huaxi Hospital Sichuan University
Chengdu, Sichuan 610044
ChinaSite Not Available
Huaxi Hospital Sichuan University
Chengdu 1815286, Sichuan 1794299 610044
ChinaCompleted
The first affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The first affiliated Hospital, Zhejiang University
Hangzhou 1808926, Zhejiang 1784764 310003
ChinaCompleted
Service d'hematologie clinique et thérapie cellulaire, Hôpital Haut-Leveque, CHU Bordeaux
Pessac, Bordeaux 33600
FranceSite Not Available
Pitie-Salpetriere Hospital, APHP-Sorbonne Universite
Paris, 75013
FranceSite Not Available
VK&K Studien GbR
Landshut, Bavaria 84036
GermanySite Not Available
Rotkreuzklinikum München
München, Bayern 80634
GermanySite Not Available
Klinikum Kassel Klinik für Onkologie und Hämatologie
Kassel, Hessen 34125
GermanySite Not Available
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, Rhineland-Palatinate 65068
GermanySite Not Available
Gemeinschaftspraxis Haematologie und Onkologie - Dresden
Dresden, 1307
GermanySite Not Available
Asklepios Klinik St Georg
Hamburg, 20099
GermanySite Not Available
Assuta Ashdod Medical Center
Ashdod, 7747629
IsraelSite Not Available
Assuta Ashdod Medical Center
Ashdod 295629, 7747629
IsraelActive - Recruiting
Soroka Medical Center
Beer Sheva, 8457108
IsraelSite Not Available
Soroka Medical Center
Beersheba 295530, 8457108
IsraelCompleted
Rambam health care campus (Department of Hematology & Bone Marrow Transplantation)
Haifa, 3109601
IsraelSite Not Available
Rambam health care campus (Department of Hematology & Bone Marrow Transplantation)
Haifa 294801, 3109601
IsraelSite Not Available
Wolfson Medical Center
Holon, 5822012
IsraelSite Not Available
Wolfson Medical Center
Holon 294751, 5822012
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 9103401
IsraelSite Not Available
Hadassah Medical Center
Jerusalem 281184, 9103401
IsraelSite Not Available
Rabin Medical Center
Petach Tikva, 4941492
IsraelSite Not Available
Rabin Medical Center
Petah Tikva 293918, 4941492
IsraelCompleted
Sourasky Medical Center
Tel Aviv, 6423906
IsraelSite Not Available
Assuta medical centers - Ramat Hachayal
Tel Aviv 293397, 6423906
IsraelCompleted
Sourasky Medical Center
Tel Aviv 293397, 6423906
IsraelSite Not Available
Assuta medical centers - Ramat Hachayal
Tel aviv, 6423906
IsraelActive - Recruiting
AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia
Ancona 3183089, Ancona 60020
ItalyActive - Recruiting
AOU Policlinico S.Orsola Malpighi di Bologna, University of Bologna
Bologna 3181928, Bologna 40138
ItalySite Not Available
UOC Ematologia ad Indirizzo Oncologico, AORN "Sant'Anna e San Sebastiano"
Caserta 3179866, Caserta 81100
ItalyActive - Recruiting
National Cancer Institute
Naples, Napoli 1-80131
ItalySite Not Available
National Cancer Institute
Naples 3172394, Napoli 1-80131
ItalyActive - Recruiting
AOU Maggiore della Carità SCDU Ematologia
Novara 3172189, Novara 28100
ItalyActive - Recruiting
DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi
Pescara 3171168, Pescara 65124
ItalyCompleted
Fondatione Policlinico Universitario A. Gemelli
Rome 3169070, Rome 00168
ItalyActive - Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Sicilia 90146
ItalySite Not Available
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo 2523920, Sicily 2523119 90146
ItalyActive - Recruiting
AOU City of Health and Science of Turin
Turin, Torino 10126
ItalySite Not Available
AOU City of Health and Science of Turin
Turin 3165524, Torino 10126
ItalyCompleted
AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia
Ancona, 60020
ItalySite Not Available
AOU Policlinico S.Orsola Malpighi di Bologna, University of Bologna
Bologna, 40138
ItalySite Not Available
UOC Ematologia ad Indirizzo Oncologico, AORN "Sant'Anna e San Sebastiano"
Caserta, 81100
ItalySite Not Available
AOU Maggiore della Carità SCDU Ematologia
Novara, 28100
ItalySite Not Available
DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi
Pescara, 65124
ItalySite Not Available
Fondatione Policlinico Universitario A. Gemelli
Rome, 00168
ItalySite Not Available
Pratia MCM Krakow
Krakow, Lesser 30-510
PolandSite Not Available
Pratia MCM Krakow
Krakow 3094802, Lesser 30-510
PolandActive - Recruiting
Szpitale Pomorskie Gdynia Dept of Haematology
Gdynia, Pomerania 81-519
PolandSite Not Available
Szpitale pomorskie gdynia dept of haematology
Gdynia, Pomerania 81-519
PolandActive - Recruiting
Szpitale pomorskie gdynia dept of haematology
Gdynia 3099424, Pomeranian Voivodeship 3337496 81-519
PolandActive - Recruiting
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu
Wroclaw, Radeckiego 50-367
PolandSite Not Available
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu
Wroclaw 3081368, Radeckiego 50-367
PolandCompleted
Pratia Onkologia Katowice
Katowice 3096472, Silesian Voivodeship 3337497 40-523
PolandCompleted
CM Pratia Poznań
Skorzewo, Wielkopolska 60819
PolandSite Not Available
Examen sp z o o
Skorzewo, Wielkopolska 60819
PolandActive - Recruiting
CM Pratia Poznań
Skorzewo 3085749, Wielkopolska 60819
PolandCompleted
Pratia Onkologia Katowice
Katowice, Śląskie 40-523
PolandSite Not Available
Institute of Hematology and Transfusion Medicine
Warsaw, 00-791
PolandSite Not Available
Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw 756135, 02-781
PolandCompleted
Institute of Hematology and Transfusion Medicine
Warsaw 756135, 00-791
PolandCompleted
Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology
Warszawa, 02-781
PolandSite Not Available
Institut català d'oncologia-hospital germans trias i pujol
Badalona, Barcelona 08916
SpainSite Not Available
Institut català d'oncologia-hospital germans trias i pujol
Badalona 3129028, Barcelona 08916
SpainActive - Recruiting
Hospital Vall Hebron
Barcelona 3128760, Barcelona 08035
SpainCompleted
Institut Catala D'oncolocia
Barcelona 3128760, Barcelona 09809
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, Madrid 3117732 28046
SpainCompleted
Hospital Virgen del Rocío
Seville 2510911, Seville 41013
SpainCompleted
Hospital Vall Hebron
Barcelona, 08035
SpainSite Not Available
Institut Catala D'oncolocia
Barcelona, 09809
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Virgen del Rocío
Seville, 41013
SpainSite Not Available
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, North West England L7 8XP
United KingdomSite Not Available
The Royal Marsden NHS Foundation Trust
Sutton, Surrey SM2 5PT
United KingdomSite Not Available
Belfast City Hospital
Belfast, BT9 7AB
United KingdomSite Not Available
Northwick Park Hospital
London, HA1 3UJ
United KingdomSite Not Available
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona 85224
United StatesSite Not Available
Arizona Oncology Associates
Tucson, Arizona 85711
United StatesSite Not Available
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler 5289282, Arizona 5551752 85224
United StatesCompleted
Arizona Oncology Associates
Tucson 5318313, Arizona 5551752 85711
United StatesActive - Recruiting
The Oncology Institute (TOI) Clinical Research
Cerritos, California 90703
United StatesSite Not Available
The Oncology Institute of Hope & Innovation
Cerritos, California 90703
United StatesActive - Recruiting
The Oncology Institute of Hope & Innovation - Downey
Downey, California 90241
United StatesSite Not Available
The Oncology Institute of Hope & Innovation - Glendale
Glendale, California 91207
United StatesSite Not Available
The Oncology Institute of Hope & Innovation - Long Beach
Long Beach, California 90805
United StatesSite Not Available
The Oncology Institute of Hope & Innovation - Santa Ana
Santa Ana, California 92705
United StatesSite Not Available
The Oncology Institute of Hope & Innovation - Whittier (Main)
Whittier, California 90602
United StatesSite Not Available
The Oncology Institute (TOI) Clinical Research
Cerritos 5335663, California 5332921 90703
United StatesActive - Recruiting
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana 46260
United StatesSite Not Available
Investigative Clinical Research of Indiana, LLC
Indianapolis 4259418, Indiana 4921868 46260
United StatesSite Not Available
Norton Cancer Institute, St. Matthews
Louisville, Kentucky 40207
United StatesSite Not Available
Norton Cancer Institute, St. Matthews
Louisville 4299276, Kentucky 6254925 40207
United StatesActive - Recruiting
Tulane Cancer Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Tulane Cancer Center
New Orleans 4335045, Louisiana 4331987 70112
United StatesSite Not Available
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United StatesSite Not Available
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89169
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas 5506956, Nevada 5509151 89169
United StatesSite Not Available
New Mexico Cancer Care Alliance
Albuquerque, New Mexico 87106
United StatesSite Not Available
New Mexico Cancer Care Alliance
Albuquerque 5454711, New Mexico 5481136 87106
United StatesSite Not Available
Stony Brook
Stony Brook, New York 11794
United StatesSite Not Available
Stony Brook
Stony Brook 5139865, New York 5128638 11794
United StatesActive - Recruiting
Gabrail Cancer Center Research LLC
Canton, Ohio 44718
United StatesSite Not Available
Gabrail Cancer Center Research LLC
Canton 5149222, Ohio 5165418 44718
United StatesSite Not Available
Texas Oncology - Medical City Dallas
Dallas, Texas 75230
United StatesSite Not Available
Texas Oncology - Presbyterian Dallas Cancer Center
Dallas, Texas 75231
United StatesSite Not Available
Texas Oncology - Sammons
Dallas, Texas 75246
United StatesSite Not Available
Texas Oncology - Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Oncology - Plano East
Plano, Texas 75075
United StatesSite Not Available
Texas Oncology - Tyler
Tyler, Texas 75702
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center
Tyler, Texas 75702
United StatesSite Not Available
Texas Oncology - Medical City Dallas
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
Texas Oncology - Presbyterian Dallas Cancer Center
Dallas 4684888, Texas 4736286 75231
United StatesSite Not Available
Texas Oncology - Sammons
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Texas Oncology - Fort Worth
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
Texas Oncology - Plano East
Plano 4719457, Texas 4736286 75075
United StatesSite Not Available
Texas Oncology - Tyler
Tyler 4738214, Texas 4736286 75702
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center
Tyler 4738214, Texas 4736286 75702
United StatesCompleted
Providence Regional Cancer Partnership
Everett, Washington 98201
United StatesSite Not Available
Providence Regional Cancer Partnership
Everett 5793933, Washington 5815135 98201
United StatesSite Not Available

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