A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

• ClinicalTrials.gov Identifier: NCT04442022
• Recruitment Status: Recruiting
• First Posted: June 22, 2020
• Last Update Posted: March 17, 2023
• Sponsor: Karyopharm Therapeutics Inc
• Information provided by (Responsible Party): Karyopharm Therapeutics Inc

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Relapsed/Refractory Diffuse Large B-cell Lymphoma	Drug: Selinexor (combination therapy); Drug: Placebo matching for Selinexor (combination therapy); Drug: Rituximab (combination therapy); Drug: Gemcitabine (combination therapy); Drug: Dexamethasone (combination therapy); Drug: Cisplatin (combination therapy); Drug: Selinexor (continuous therapy); Drug: Placebo matching for Selinexor (continuous therapy)	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 501 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Phase 2 Portion of the Study: open label; Phase 3 Portion of the Study: double blinded
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: September 3, 2020
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phase 2: Selinexor 40 mg + R-GDP; Patients with RR DLBCL will receive combination therapy of selinexor 40 mg orally at Day 1, and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally once weekly (QW) for each 28-day cycle until progressive disease (PD) or unacceptable toxicity.	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: Rituximab (combination therapy); Dose: 375 milligram per meter square (mg/m^2) on Day 1; Route of administration: intravenous (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
Experimental: Phase 2: Selinexor 60 mg + R-GDP; Patients with RR DLBCL will receive combination therapy of selinexor 60 mg orally at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.	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: 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
Active Comparator: Phase 2: R-GDP; Patients with RR DLBCL will receive R-GDP on specified days (Days 1, 2, 3, 4, and 8) for each 21-day cycle for up to 6 cycles.	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
Experimental: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg; Patients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.	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: 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
Experimental: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo; Patients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.	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: 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: 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
Placebo Comparator: Phase 3: Placebo + R-GDP followed by Placebo; Patients with RR DLBCL will receive combination therapy of placebo matching for selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.	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 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: 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

Outcome Measures

Primary Outcome Measures :

1. Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014 [ Time Frame: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization) ]
2. Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014 [ Time Frame: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization) ]

Secondary Outcome Measures :

1. Phase 2: Progression-free Survival: Based on Lugano Criteria 2014 [ Time Frame: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization) ]
2. Phase 2: Overall Survival (OS) [ Time Frame: From date of initial randomization until death (maximum of 5 years from randomization) ]
3. Phase 3: Overall Response Rate: Based on Lugano Criteria 2014 [ Time Frame: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization) ]
4. Phase 3: Overall Survival [ Time Frame: From date of initial randomization until death (maximum of 5 years from randomization) ]
5. Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014 [ Time Frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy ]
6. Phase 2: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria [ Time Frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy ]
7. Phase 2: Duration of Response (DOR): Based on Lugano Criteria 2014 [ Time Frame: From time of first response until disease progression or death (maximum of 5 years from randomization) ]
8. Phase 2: Number of Patients with Adverse Events (AEs) [ Time Frame: Up to 30 days after last dose of study drug (maximum of 5 years from randomization) ]
9. Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Lugano Criteria 2014 [ Time Frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy ]
10. Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria [ Time Frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy ]
11. Phase 3: Duration of Response: Based on Lugano Criteria 2014 [ Time Frame: From time of first response until disease progression or death (maximum of 5 years from randomization) ]
12. Phase 3: Progression-free Survival: Based on Modified Lugano Criteria [ Time Frame: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization) ]
13. Phase 3: Number of Patients with Adverse Events [ Time Frame: Up to 30 days after last dose of study drug (maximum of 5 years from randomization) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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/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 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/CT 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 (/L).
  • Platelet count ≥100*10^9/L (without platelet transfusion less than [<] 14 days prior 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) ≤2.5*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/min) 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.

Exclusion Criteria:

• 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) <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 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.
• 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 days prior to C1D1
  • Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot discontinue 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 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 <100 International units (IU)/mL 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.

Contacts and Locations

Contacts

Contact: Karyopharm Medical Information; (888) 209-9326; clinicaltrials@karyopharm.com

Locations

United States, Arizona

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers; Recruiting

Chandler, Arizona, United States, 85224

Contact: Sujith Kalmadi, MD 480-821-2838 kalmadi@ironwoodcrc.com

Principal Investigator: Sujith Kalmadi, MD

Arizona Oncology Associates; Recruiting

Tucson, Arizona, United States, 85711

Contact: Sudhir Manda, MD 520-886-0206 sudhir.manda@usoncology.com

Principal Investigator: Sudhir Manda, MD

United States, California

The Oncology Institute of Hope & Innovation; Recruiting

Whittier, California, United States, 90602

Contact: Merrill Shum, MD 562-693-4477 mshum@airesearch.us

Principal Investigator: Merrill Shum, MD

United States, Indiana

Investigative Clinical Research of Indiana, LLC; Withdrawn

Indianapolis, Indiana, United States, 46260

United States, Kentucky

Norton Cancer Institute, St. Matthews; Recruiting

Louisville, Kentucky, United States, 40207

Contact: Don Stevens, MD 502-899-3366 don.stevens@nortonhealthcare.org

Principal Investigator: Don Stevens, MD

United States, Louisiana

Tulane Cancer Center; Completed

New Orleans, Louisiana, United States, 70112

United States, Maryland

University of Maryland Greenebaum Comprehensive Cancer Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Seung Tae Lee, MD 410-328-8708 seunglee@umm.edu

Principal Investigator: Seung Tae Lee, MD

United States, Nevada

Comprehensive Cancer Centers of Nevada - Town Center; Terminated

Las Vegas, Nevada, United States, 89169

United States, New Mexico

New Mexico Cancer Care Alliance; Terminated

Albuquerque, New Mexico, United States, 87106

United States, New York

Stony Brook; Recruiting

Stony Brook, New York, United States, 11794

Contact: Thomas Jandl, MD 631-638-1000 thomas.jandl@stonybrookmedicine.edu

Principal Investigator: Thomas Jandl, MD

United States, Ohio

Gabrail Cancer Center Research LLC; Withdrawn

Canton, Ohio, United States, 44718

United States, Texas

Texas Oncology - Medical City Dallas; Terminated

Dallas, Texas, United States, 75230

Texas Oncology - Presbyterian Dallas Cancer Center; Recruiting

Dallas, Texas, United States, 75231

Contact: Kristi McIntyre, MD 214-739-4175 kristi.mcintyre@usoncology.com

Principal Investigator: Kristi McIntyre, MD

Texas Oncology - Sammons; Recruiting

Dallas, Texas, United States, 75246

Contact: Moshe Yair Levy, MD 214-370-1000 yair.levy@usoncology.com

Principal Investigator: Moshe Yair Levy, MD

Texas Oncology - Fort Worth; Terminated

Fort Worth, Texas, United States, 76104

Texas Oncology - Plano East; Withdrawn

Plano, Texas, United States, 75075

Texas Oncology - Tyler; Recruiting

Tyler, Texas, United States, 75702

Contact: Habte Yimer, MD 903-579-9800 habte.yimer@usoncology.com

Principal Investigator: Habte Yimer, MD

The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center; Recruiting

Tyler, Texas, United States, 75702

Contact: Marc Usrey, MD 903-595-7044 Marc.Usrey@uthct.edu

Principal Investigator: Marc Usrey, MD

United States, Washington

Providence Regional Cancer Partnership; Recruiting

Everett, Washington, United States, 98201

Contact: Ajay Kundra, MD 425-297-5577 akundra@everettclinic.com

Principal Investigator: Ajay Kundra, MD

Austria

Kepler Universitaetskrankenhaus Med Campu III - Onkologie; Completed

Linz, Austria, 4021

University of Vienna, Medical Clinic I, Hematology; Completed

Vienna, Austria, 1090

Hospital Hietzing; Completed

Vienna, Austria, 1130

China, Jiangsu

Jiangsu Province Hospital; Not yet recruiting

Nanjing, Jiangsu, China, 210029

Contact: Xu Wei +86 139-5169-9449 Xuwei0484@jsph.org.cn

Principal Investigator: Xu Wei

The First Affiliated Hospital of Soochow University; Recruiting

Suzhou, Jiangsu, China, 215006

Contact: Wu Depei +86 139-5110-2021 drwudepei@163.com

Principal Investigator: Wu Depei

China, Shanghai

Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School; Recruiting

Huangpu, Shanghai, China, 200025

Contact: Zhao Weili +86 135-1211-2076 zwl_trial@163.com

Principal Investigator: Zhao Weili

Zhongshan Hospital Fudan University; Not yet recruiting

Xuhui District, Shanghai, China, 200032

Contact: Liu Peng +86 138-1769-2514 liu.peng@zs-hospital.sh.cn

Principal Investigator: Liu Peng

China, Sichuan

Huaxi Hospital Sichuan University; Not yet recruiting

Chengdu, Sichuan, China, 610044

Contact: Zou Liqun +86 189-8060-1027 zliqun@hotmail.com

Principal Investigator: Zou Liqun

China, Zhejiang

The first affiliated Hospital, Zhejiang University; Recruiting

Hangzhou, Zhejiang, China, 310003

Contact: Jin Jie +86 135-0571-6779 jiej0503@163.com

Principal Investigator: Jin Jie

Israel

Assuta Ashdod Medical Center; Recruiting

Ashdod, Israel, 7747629

Contact: Merav Leiba, MD +972 58 666 9161 meravlei@assuta.co.il

Principal Investigator: Merav Leiba, MD

Soroka Medical Center; Recruiting

Beer Sheva, Israel, 8457108

Contact: Itai Levi, MD +972 54 4203424 etail@clalit.org.il

Principal Investigator: Itai Levi, MD

Rambam health care campus (Department of Hematology & Bone Marrow Transplantation); Recruiting

Haifa, Israel, 3109601

Contact: Shimrit Ringelstein-Harlev, MD +972 4 777 3705 s_ringelstein@rambam.health.gov.il

Principal Investigator: Shimrit Ringelstein-Harlev, MD

Wolfson Medical Center; Recruiting

Holon, Israel, 5822012

Contact: Asher Winder, MD +972 3 502 8778 winder@wmc.gov.il

Principal Investigator: Asher Winder, MD

Hadassah Medical Center; Recruiting

Jerusalem, Israel, 9103401

Contact: Neta Goldschmidt, MD 972-508573679 neta@hadassah.org.il

Principal Investigator: Neta Goldschmidt, MD

Rabin Medical Center; Recruiting

Petach Tikva, Israel, 4941492

Contact: Ronit Gurion, MD +972 50 406 5336 Ronitgurion@gmail.com

Principal Investigator: Ronit Gurion, MD

Assuta medical centers - Ramat Hachayal; Recruiting

Tel aviv, Israel, 6423906

Contact: Ofer Shpilberg, MD 97237644942 ofers@assuta.co.il

Principal Investigator: Ofer Shpilberg, MD

Sourasky Medical Center; Recruiting

Tel Aviv, Israel, 6423906

Contact: Irit Avivi, MD 972-3-6973782 iritavi@tlvmc.gov.il

Principal Investigator: Irit Avivi, MD

Italy

National Cancer Institute; Recruiting

Naples, Napoli, Italy, 1-80131

Contact: Antonio Pinto, MD +39 81 590 3382 a.pinto@istitutotumori.na.it

Principal Investigator: Antonio Pinto, MD

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello; Recruiting

Palermo, Sicilia, Italy, 90146

Contact: Caterina Patti, MD +39 91 780 2037 k.patti@ospedaliriunitipalermo.it

Principal Investigator: Caterina Patti, MD

AOU City of Health and Science of Turin; Not yet recruiting

Turin, Torino, Italy, 10126

Contact: Federica Cavallo, MD +39 11 633 4264 f.cavallo@unito.it

Principal Investigator: Federica Cavallo, MD

AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia; Recruiting

Ancona, Italy, 60020

Contact: Guido Gini, MD +39 71 596 4562/4235 guido.gini@ospedaliriuniti.marche.it

Principal Investigator: Guido Gini, MD

AOU Policlinico S.Orsola Malpighi di Bologna, University of Bologna; Not yet recruiting

Bologna, Italy, 40138

Contact: Pier Luigi Zinzani, MD +39 51 214 3680 pierluigi.zinzani@unibo.it

Principal Investigator: Pier Luigi Zinzani, MD

UOC Ematologia ad Indirizzo Oncologico, AORN "Sant'Anna e San Sebastiano"; Recruiting

Caserta, Italy, 81100

Contact: Ferdinando Frigeri, MD +39 82 323 2192 ferdinando.frigeri@aorncaserta.it

Principal Investigator: Ferdinando Frigeri, MD

AOU Maggiore della Carità SCDU Ematologia; Recruiting

Novara, Italy, 28100

Contact: Gianluca Gaidano, MD +39 321 373 2194 gianluca.gaidano@med.uniupo.it

Principal Investigator: Gianluca Gaidano, MD

DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi; Not yet recruiting

Pescara, Italy, 65124

Contact: Elsa Pennese, MD +39 347 307 9075 elsapennese@gmail.com

Principal Investigator: Elsa Pennese, MD

Fondatione Policlinico Universitario A. Gemelli; Recruiting

Rome, Italy, 168

Contact: Stefan Hohaus, MD +39 63 015 4180 stefan.hohaus@unicatt.it

Principal Investigator: Stefan Hohaus, MD

Poland

Pratia MCM Krakow; Recruiting

Krakow, Lesser, Poland, 30-510

Contact: Wojciech Jurczak, MD 48602338290 wojciech.jurczak@pratia.com

Principal Investigator: Wojciech Jurczak, MD

Szpitale pomorskie gdynia dept of haematology; Recruiting

Gdynia, Pomerania, Poland, 81-519

Contact: Wanda Knopinska-Posluszny, MD +48 58 726 0570 wanda.knopinska@gmail.com

Principal Investigator: Wanda Knopinska-Posluszny, MD

Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu; Recruiting

Wroclaw, Radeckiego, Poland, 50-367

Contact: Tomasz Wrobel tomasz_wrobel@wp.pl

Principal Investigator: Tomasz Wrobel

Examen sp z o o; Recruiting

Skorzewo, Wielkopolska, Poland, 60819

Contact: Maciej Kazmierczak, MD +48506969916 kontakt@examen.pl

Principal Investigator: Maciej Kazmierczak, MD

Institute of Hematology and Transfusion Medicine; Not yet recruiting

Warsaw, Poland, 00-791

Contact: Ewa Lech-Maranda, MD 48223496454 emaranda@ihit.waw.pl

Principal Investigator: Ewa Lech-Maranda, MD

Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology; Not yet recruiting

Warszawa, Poland, 02-781

Contact: Jan Walewski, MD +48 22 546 3248 jan.walewski@pib-nio.pl

Principal Investigator: Jan Walewski, MD

Pratia Onkologia Katowice; Recruiting

Katowice, Śląskie, Poland, 40-523

Contact: Sebastian Grosicki +48 501 714 089 sgrosicki@wp.pl

Principal Investigator: Sebastian Grosicki

Spain

Institut català d'oncologia-hospital germans trias i pujol; Recruiting

Badalona, Barcelona, Spain, 8916

Contact: Juan Manuel Sancho, MD +34 93 497 8987 jsancho@iconcologia.net

Principal Investigator: Juan Manuel Sancho, MD

Hospital Vall Hebron; Recruiting

Barcelona, Spain, 8035

Contact: Pau Abrisqueta, MD +34 93 489 3000 ext 4895 pabrisqueta@vhebron.net

Principal Investigator: Pau Abrisqueta, MD

Institut Catala D'oncolocia; Recruiting

Barcelona, Spain, 9809

Contact: Anna Sureda, MD +34 93 260 7750 asureda@iconcologio.net

Principal Investigator: Anna Sureda, MD

Hospital Universitario La Paz; Recruiting

Madrid, Spain, 28046

Contact: Miguel Canales, MD +34 91 727 7116 mcanales.hematologia@gmail.com

Principal Investigator: Miguel Canales, MD

Hospital Virgen del Rocío; Recruiting

Seville, Spain, 41013

Contact: Fatima De la Cruz, MD +34 95 501 3277 fatimadelacruzv@gmail.com

Principal Investigator: Fatima De la Cruz, MD

Sponsors and Collaborators

Karyopharm Therapeutics Inc

More Information

• Responsible Party: Karyopharm Therapeutics Inc
• ClinicalTrials.gov Identifier: NCT04442022
• Other Study ID Numbers: XPORT-DLBCL-030; 2020-000605-84 ( EudraCT Number )
• First Posted: June 22, 2020
• Last Update Posted: March 17, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karyopharm Therapeutics Inc:

Relapsed/Refractory DLBCL; Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP); Selinexor; Karyopharm; KCP-330; XPOVIO; DLBCL; XPORT-DLBCL-030; R-GDP

Additional relevant MeSH terms:

Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Gemcitabine; Dexamethasone; Rituximab; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action