[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04442022":3,"trial-entities:NCT04442022":462,"trial-summary:NCT04442022":466},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":34,"interventions":37,"primary_outcomes":86,"secondary_outcomes":93,"sex":124,"minimum_age":125,"maximum_age":17,"healthy_volunteers":126,"eligibility_criteria":127,"std_ages":175,"locations":178,"central_contacts":458,"overall_officials":459,"references":460,"see_also_links":461},"NCT04442022","XPORT-DLBCL-030","A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","A Phase 2\u002F3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma (RR DLBCL)","ACTIVE_NOT_RECRUITING","2026-12","2026-06","2026-07-02","2020-09-03","Karyopharm Therapeutics Inc","INDUSTRY",true,"The purpose of this Phase 2\u002F3 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.",null,[19],"Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma",[21,22,23,24,25,26,27,5,28],"Relapsed\u002FRefractory DLBCL","Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP)","Selinexor","Karyopharm","KCP-330","XPOVIO","DLBCL","R-GDP","INTERVENTIONAL","TREATMENT",[32,33],"PHASE2","PHASE3",{"count":35,"type":36},501,"ESTIMATED",[38,44,48,53,58,62,66,70,74,78,82],{"type":39,"name":40,"description":41,"armGroupLabels":42},"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",[43],"Phase 2: Selinexor 40 mg + R-GDP",{"type":39,"name":40,"description":45,"armGroupLabels":46},"Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral",[47],"Phase 2: Selinexor 60 mg + R-GDP",{"type":39,"name":40,"description":49,"armGroupLabels":50},"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",[51,52],"Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo","Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg",{"type":39,"name":54,"description":55,"armGroupLabels":56},"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",[57],"Phase 3: Placebo + R-GDP followed by Placebo",{"type":39,"name":59,"description":60,"armGroupLabels":61},"Rituximab (combination therapy)","Dose: 375 milligram per meter square (mg\u002Fm\\^2) on Day 1; Route of administration: intravenous (IV)",[43],{"type":39,"name":59,"description":63,"armGroupLabels":64},"Dose: 375 mg\u002Fm\\^2 on Day 1; Route of administration: IV",[65,47,57,51,52],"Phase 2: R-GDP",{"type":39,"name":67,"description":68,"armGroupLabels":69},"Gemcitabine (combination therapy)","Dose: 1000 mg\u002Fm\\^2 on Days 1 and 8; Route of administration: IV",[65,43,47,57,51,52],{"type":39,"name":71,"description":72,"armGroupLabels":73},"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",[65,43,47,57,51,52],{"type":39,"name":75,"description":76,"armGroupLabels":77},"Cisplatin (combination therapy)","Dose: 75 mg\u002Fm\\^2 on Day 1; Route of administration: IV",[65,43,47,57,51,52],{"type":39,"name":79,"description":80,"armGroupLabels":81},"Selinexor (continuous therapy)","Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral",[43,47,52],{"type":39,"name":83,"description":84,"armGroupLabels":85},"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",[57,51],[87,90],{"measure":88,"timeFrame":89},"Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014","From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)",{"measure":91,"timeFrame":92},"Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014","From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)",[94,96,99,101,103,106,108,111,114,116,118,120,122],{"measure":95,"timeFrame":92},"Phase 2: Progression-free Survival: Based on Lugano Criteria 2014",{"measure":97,"timeFrame":98},"Phase 2: Overall Survival (OS)","From date of initial randomization until death (maximum of 5 years from randomization)",{"measure":100,"timeFrame":89},"Phase 3: Overall Response Rate: Based on Lugano Criteria 2014",{"measure":102,"timeFrame":98},"Phase 3: Overall Survival",{"measure":104,"timeFrame":105},"Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014","From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy",{"measure":107,"timeFrame":105},"Phase 2: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria",{"measure":109,"timeFrame":110},"Phase 2: Duration of Response (DOR): Based on Lugano Criteria 2014","From time of first response until disease progression or death (maximum of 5 years from randomization)",{"measure":112,"timeFrame":113},"Phase 2: Number of Patients with Adverse Events (AEs)","Up to 30 days after last dose of study drug (maximum of 5 years from randomization)",{"measure":115,"timeFrame":105},"Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Lugano Criteria 2014",{"measure":117,"timeFrame":105},"Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria",{"measure":119,"timeFrame":110},"Phase 3: Duration of Response: Based on Lugano Criteria 2014",{"measure":121,"timeFrame":92},"Phase 3: Progression-free Survival: Based on Modified Lugano Criteria",{"measure":123,"timeFrame":113},"Phase 3: Number of Patients with Adverse Events","ALL","18 Years",false,{"inclusion":128,"exclusion":168,"raw_text":174},[129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167],"Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\u002For 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 the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.","Salvage chemoimmunotherapy followed by stem cell transplantation will be considered 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 1 line of systemic therapy.","Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\>1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\u002FCT should be between 3 to 5.","Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent \\[%\\] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT 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 (\u002FL).","Platelet count ≥100\\*10\\^9\u002FL (without platelet transfusion less than \\[\\\u003C\\] 14 days prior to Cycle 1 Day 1 \\[C1D1\\]).","Hemoglobin ≥8.5 gram per deciliter (g\u002FdL) (without red blood cell transfusion \\\u003C14 days prior to C1D1).","Circulating lymphocytes less than or equal to (≤) 50\\*10\\^9\u002FL.","Adequate liver and kidney function, defined as:","Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5\\*upper limit of normal (ULN), or ≤5\\*ULN in cases with known lymphoma involvement in the liver.","Serum total bilirubin ≤2\\*ULN, or ≤5\\*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.","Calculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL\u002Fmin) based on 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 6 months after ending first-line treatment, will be allowed in the study.","Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment","Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age \\>50 years and naturally amenorrhoeic for \\>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).","Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.","Major surgery \\\u003C14 days of Cycle 1 Day 1.","Hematopoietic stem cell transplantation\u002FCAR-T therapy as follows:","Autologous stem cell transplant (SCT) \\\u003C100 days or allogeneic-SCT \\\u003C180 days prior to C1D1","Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis)","CAR-T cell infusion \\\u003C90 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 being compliant 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 human immunodeficiency virus (HIV) infections:","Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for \\>8 weeks and viral load is \\\u003C100 International units (IU)\u002FmL prior to first dose of study treatment.","Patients 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.","Patients with HIV are allowed if they have a negative viral load per institutional 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 ideal body weight.","Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.",[169,170,171,172,173],"DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma \\[NHL\\]), DLBCL transformed from diseases other 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 of Screening.","Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \\\u003C21 days prior to C1D1 (prednisone \\\u003C30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions).","Inclusion Criteria:\n\n* Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade lymphoma with c-MYC, Bcl2 and\u002For Bcl6 rearrangements are eligible (only for Phase 2). (Documentation to be provided).\n* Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen.\n\n  * Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy.\n  * Maintenance therapy will not be counted as a separate line of systemic therapy.\n  * Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy.\n* Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\>1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale (D5PS) score assessed on the FDG PET\u002FCT should be between 3 to 5.\n* Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15 percent \\[%\\] of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.\n* Adequate bone marrow function at screening, defined as:\n\n  * Absolute neutrophil count (ANC) ≥1\\*10\\^9 per liter (\u002FL).\n  * Platelet count ≥100\\*10\\^9\u002FL (without platelet transfusion less than \\[\\\u003C\\] 14 days prior to Cycle 1 Day 1 \\[C1D1\\]).\n  * Hemoglobin ≥8.5 gram per deciliter (g\u002FdL) (without red blood cell transfusion \\\u003C14 days prior to C1D1).\n* Circulating lymphocytes less than or equal to (≤) 50\\*10\\^9\u002FL.\n* Adequate liver and kidney function, defined as:\n\n  * Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5\\*upper limit of normal (ULN), or ≤5\\*ULN in cases with known lymphoma involvement in the liver.\n  * Serum total bilirubin ≤2\\*ULN, or ≤5\\*ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver.\n  * Calculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL\u002Fmin) based on Cockcroft-Gault formula.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n* An estimated life expectancy of \\>3 months at Screening.\n* Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment, will be allowed in the study.\n* Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment\n* Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with Non-Childbearing potential: Age \\>50 years and naturally amenorrhoeic for \\>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\n* Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.\n\nExclusion Criteria:\n\n* DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma \\[NHL\\]), DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma.\n* Previous treatment with selinexor or other XPO1 inhibitors.\n* Contraindication to any drug contained in the combination therapy regimen (SR-GDP).\n* Known active central nervous system or meningeal involvement by DLBCL at time of Screening.\n* Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \\\u003C21 days prior to C1D1 (prednisone \\\u003C30 mg or equivalent is permitted; palliative radiation is permitted only if on non-target lesions).\n* Any AE, by C1D1, which has not recovered to Grade ≤1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\], v.5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (as specified in the inclusion criteria) and alopecia.\n* Major surgery \\\u003C14 days of Cycle 1 Day 1.\n* Hematopoietic stem cell transplantation\u002FCAR-T therapy as follows:\n\n  * Autologous stem cell transplant (SCT) \\\u003C100 days or allogeneic-SCT \\\u003C180 days prior to C1D1\n  * Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue GVHD treatment or prophylaxis)\n  * CAR-T cell infusion \\\u003C90 days prior to Cycle 1\n* Neuropathy Grade ≥2 (CTCAE, v.5.0).\n* Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or being compliant with the study procedures.\n* 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).\n* Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections:\n\n  * Patient with active HBV are allowed if antiviral therapy for hepatitis B has been given for \\>8 weeks and viral load is \\\u003C100 International units (IU)\u002FmL prior to first dose of study treatment.\n  * Patients 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.\n  * Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year.\n* Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal (GI) disease or dysfunction that could interfere with absorption of study treatment.\n* Breastfeeding or pregnant women.\n* Inability or unwillingness to sign an informed consent form (ICF).\n* In the opinion of the Investigator, patient who are significantly below their ideal body weight.\n* Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment.",[176,177],"ADULT","OLDER_ADULT",[179,188,195,203,211,219,226,234,237,246,253,261,268,276,284,292,299,306,313,321,328,336,343,350,357,365,373,382,390,398,406,414,421,425,434,440,444,451],{"facility":180,"city":181,"state":182,"zip":183,"country":184,"geoPoint":185},"Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers","Chandler","Arizona","85224","United States",{"lat":186,"lon":187},33.30616,-111.84125,{"facility":189,"city":190,"state":182,"zip":191,"country":184,"geoPoint":192},"Arizona Oncology Associates","Tucson","85711",{"lat":193,"lon":194},32.22174,-110.92648,{"facility":196,"city":197,"state":198,"zip":199,"country":184,"geoPoint":200},"The Oncology Institute (TOI) Clinical Research","Cerritos","California","90703",{"lat":201,"lon":202},33.85835,-118.06479,{"facility":204,"city":205,"state":206,"zip":207,"country":184,"geoPoint":208},"Norton Cancer Institute, St. Matthews","Louisville","Kentucky","40207",{"lat":209,"lon":210},38.25424,-85.75941,{"facility":212,"city":213,"state":214,"zip":215,"country":184,"geoPoint":216},"University of Maryland Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"lat":217,"lon":218},39.29038,-76.61219,{"facility":220,"city":220,"state":221,"zip":222,"country":184,"geoPoint":223},"Stony Brook","New York","11794",{"lat":224,"lon":225},40.92565,-73.14094,{"facility":227,"city":228,"state":229,"zip":230,"country":184,"geoPoint":231},"Texas Oncology - Tyler","Tyler","Texas","75702",{"lat":232,"lon":233},32.35126,-95.30106,{"facility":235,"city":228,"state":229,"zip":230,"country":184,"geoPoint":236},"The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center",{"lat":232,"lon":233},{"facility":238,"city":239,"state":240,"zip":241,"country":242,"geoPoint":243},"Jiangsu Province Hospital","Nanjing","Jiangsu","210029","China",{"lat":244,"lon":245},32.06167,118.77778,{"facility":247,"city":248,"state":240,"zip":249,"country":242,"geoPoint":250},"The First Affiliated Hospital of Soochow University","Suzhou","215006",{"lat":251,"lon":252},31.30408,120.59538,{"facility":254,"city":255,"state":256,"zip":257,"country":242,"geoPoint":258},"Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School","Huangpu","Shanghai Municipality","200025",{"lat":259,"lon":260},31.2378,121.4781,{"facility":262,"city":263,"state":256,"zip":264,"country":242,"geoPoint":265},"Zhongshan Hospital Fudan University","Xuhui","200032",{"lat":266,"lon":267},31.19594,121.44709,{"facility":269,"city":270,"state":271,"zip":272,"country":242,"geoPoint":273},"Huaxi Hospital Sichuan University","Chengdu","Sichuan","610044",{"lat":274,"lon":275},30.66667,104.06667,{"facility":277,"city":278,"state":279,"zip":280,"country":242,"geoPoint":281},"The first affiliated Hospital, Zhejiang University","Hangzhou","Zhejiang","310003",{"lat":282,"lon":283},30.29365,120.16142,{"facility":285,"city":286,"zip":287,"country":288,"geoPoint":289},"Assuta Ashdod Medical Center","Ashdod","7747629","Israel",{"lat":290,"lon":291},31.79213,34.64966,{"facility":293,"city":294,"zip":295,"country":288,"geoPoint":296},"Soroka Medical Center","Beersheba","8457108",{"lat":297,"lon":298},31.25181,34.7913,{"facility":300,"city":301,"zip":302,"country":288,"geoPoint":303},"Rabin Medical Center","Petah Tikva","4941492",{"lat":304,"lon":305},32.0888,34.88666,{"facility":307,"city":308,"zip":309,"country":288,"geoPoint":310},"Assuta medical centers - Ramat Hachayal","Tel Aviv","6423906",{"lat":311,"lon":312},32.08088,34.78057,{"facility":314,"city":315,"state":315,"zip":316,"country":317,"geoPoint":318},"AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia","Ancona","60020","Italy",{"lat":319,"lon":320},43.60717,13.5103,{"facility":322,"city":323,"state":323,"zip":324,"country":317,"geoPoint":325},"UOC Ematologia ad Indirizzo Oncologico, AORN \"Sant'Anna e San Sebastiano\"","Caserta","81100",{"lat":326,"lon":327},41.07262,14.33231,{"facility":329,"city":330,"state":331,"zip":332,"country":317,"geoPoint":333},"National Cancer Institute","Naples","Napoli","1-80131",{"lat":334,"lon":335},40.85216,14.26811,{"facility":337,"city":338,"state":338,"zip":339,"country":317,"geoPoint":340},"AOU Maggiore della Carità SCDU Ematologia","Novara","28100",{"lat":341,"lon":342},45.44694,8.62118,{"facility":344,"city":345,"state":345,"zip":346,"country":317,"geoPoint":347},"DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi","Pescara","65124",{"lat":348,"lon":349},42.4584,14.20283,{"facility":351,"city":352,"state":352,"zip":353,"country":317,"geoPoint":354},"Fondatione Policlinico Universitario A. Gemelli","Rome","00168",{"lat":355,"lon":356},41.89193,12.51133,{"facility":358,"city":359,"state":360,"zip":361,"country":317,"geoPoint":362},"Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello","Palermo","Sicily","90146",{"lat":363,"lon":364},38.1166,13.3636,{"facility":366,"city":367,"state":368,"zip":369,"country":317,"geoPoint":370},"AOU City of Health and Science of Turin","Turin","Torino","10126",{"lat":371,"lon":372},45.07049,7.68682,{"facility":374,"city":375,"state":376,"zip":377,"country":378,"geoPoint":379},"Pratia MCM Krakow","Krakow","Lesser","30-510","Poland",{"lat":380,"lon":381},50.06143,19.93658,{"facility":383,"city":384,"state":385,"zip":386,"country":378,"geoPoint":387},"Szpitale pomorskie gdynia dept of haematology","Gdynia","Pomeranian Voivodeship","81-519",{"lat":388,"lon":389},54.51889,18.53188,{"facility":391,"city":392,"state":393,"zip":394,"country":378,"geoPoint":395},"Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu","Wroclaw","Radeckiego","50-367",{"lat":396,"lon":397},51.10286,17.03006,{"facility":399,"city":400,"state":401,"zip":402,"country":378,"geoPoint":403},"Pratia Onkologia Katowice","Katowice","Silesian Voivodeship","40-523",{"lat":404,"lon":405},50.2597,19.02173,{"facility":407,"city":408,"state":409,"zip":410,"country":378,"geoPoint":411},"CM Pratia Poznań","Skorzewo","Wielkopolska","60819",{"lat":412,"lon":413},54.16909,17.97006,{"facility":415,"city":416,"zip":417,"country":378,"geoPoint":418},"Institute of Hematology and Transfusion Medicine","Warsaw","00-791",{"lat":419,"lon":420},52.22977,21.01178,{"facility":422,"city":416,"zip":423,"country":378,"geoPoint":424},"Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology","02-781",{"lat":419,"lon":420},{"facility":426,"city":427,"state":428,"zip":429,"country":430,"geoPoint":431},"Institut català d'oncologia-hospital germans trias i pujol","Badalona","Barcelona","08916","Spain",{"lat":432,"lon":433},41.45004,2.24741,{"facility":435,"city":428,"state":428,"zip":436,"country":430,"geoPoint":437},"Hospital Vall Hebron","08035",{"lat":438,"lon":439},41.38879,2.15899,{"facility":441,"city":428,"state":428,"zip":442,"country":430,"geoPoint":443},"Institut Catala D'oncolocia","09809",{"lat":438,"lon":439},{"facility":445,"city":446,"state":446,"zip":447,"country":430,"geoPoint":448},"Hospital Universitario La Paz","Madrid","28046",{"lat":449,"lon":450},40.4165,-3.70256,{"facility":452,"city":453,"state":453,"zip":454,"country":430,"geoPoint":455},"Hospital Virgen del Rocío","Seville","41013",{"lat":456,"lon":457},37.38283,-5.97317,[],[],[],[],{"nct_id":4,"conditions":463,"biomarkers":465},[464],"Diffuse Large B-Cell Lymphoma",[],{"nct_id":4,"found":15,"summary":467,"prompt_version":477},{"design":468,"status":469,"heading":470,"summary":471,"follow_up":472,"word_count":473,"commitments":474,"compensation":475,"drugs_mentioned":476},"This is a Phase 2\u002F3 study, meaning it's testing different doses of selinexor and then comparing the best dose to a placebo. It plans to enroll 501 participants.","completed","A Study of Selinexor with R-GDP for Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","This study is looking at a treatment for relapsed\u002Frefractory diffuse large B-cell lymphoma (DLBCL), which means the lymphoma has come back or didn't respond to previous treatments. It's testing a combination of drugs called selinexor and R-GDP (Rituximab, Gemcitabine, Dexamethasone, Platinum). The study aims to see how well this combination works and if it's safe for people who are not planning to have a stem cell transplant or CAR-T cell therapy. You might be able to join if you are 18 or older and have a confirmed diagnosis of DLBCL. The study will measure how many people respond to the treatment and how long they live without their disease getting worse, for up to 5 years.","Your progress will be monitored for up to 5 years from the start of the study to see how long you live without your disease getting worse or needing new treatment.",116,"You would receive selinexor (oral) or a matching placebo, along with Rituximab (IV), for up to 6 cycles, with each cycle lasting 21 days. If you respond, you might continue with selinexor alone.","Not stated in the trial record.",[],"v2"]