Selinexor for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This study is testing an oral medication called selinexor (KPT-330) for people with diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to previous treatments (relapsed/refractory). You might be able to join if you are at least 18 years old and have no other treatment options with proven benefits. The study aims to see how many people respond to selinexor, measured by how much their cancer shrinks or disappears (Overall Response Rate). The study is currently unclear on its recruitment status. Participants will receive either 40 mg or 60 mg of selinexor, taken by mouth twice a week.
- Study design
- This is an open-label, Phase 2b study involving 244 participants. It has two parts: Part 1 gives a fixed 60 mg dose, and Part 2 randomly assigns participants to either a 40 mg or 60 mg dose.
- What's involved
- Participants will take selinexor orally until their disease progresses or they can no longer tolerate the treatment. All participants will be followed until their disease progresses or they pass away.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part 1 will have their response measured at one year. For Part 2, response is measured from randomization until disease progression or death, up to a maximum of one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT02227251
Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentKaryopharm Therapeutics Inc
~244 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Selinexor
At a glance
Recruiting sites
0 of 175 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Overall Response Rate (ORR)
Measured over One year
+1 more outcome measured
Conditions
NCT02227251
Where you'd take part
This study runs at 175 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Addenbrooke's Hospital Cambridge
Cambridge, United Kingdomno site contact published
Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie
Linz, Austriano site contact published
AOU Maggiore della Carità SCDU Ematologia
Florence, Italyno site contact published
Ashford Cancer Centre
Kurralta Park, South Australia, Australiano site contact published
Assuta Medical Center
Tel Aviv, Israelno site contact published
AZ Delta
Roeselare, Belgiumno site contact published
AZ Sint-Jan
Bruges, Belgiumno site contact published
Azienda Ospedaliero-Universitaria Senese
Siena, Italyno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Written informed consent in accordance with federal, local, and institutional guidelines. The participant must provide informed consent prior to the first screening procedure.
Age greater than or equal to (≥) 18 years.
ECOG performance status of less than or equal to (≤) 2.
Participants should have estimated life expectancy of greater than (\>) 3 months at study entry.
Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
Participants must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL including (i) at least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Participants who were considered ineligible for standard multi-agent immunochemotherapy must have received at least 2 and no more than 5 prior treatment regimens including at least 1 course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
Female participants of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception for 3 months after their last dose of medication. Male participants must use a reliable method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose.
For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other participants, at least 14 weeks (98 days) must have elapsed since the end of their most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered anti DLBCL therapy, and therefore is allowed during the therapy-free interval.
Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is \>1.0. Lymph nodes ≤1.0 by ≤1.0 will not be considered abnormal for relapse or PD.
Participants must have measurable disease per the revised criteria for response assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is \>1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal if the long axis is \>1.0 cm.
Exclusion
Participants who are pregnant or lactating.
Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
Participants must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (Investigator must provide detailed documentation for ineligibility).
Participants who have not recovered to Grade ≤1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
Major surgery within 2 weeks of first dose of study treatment.
Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infections.
Psychiatric illness or substance use that would prevent the participant from giving informed consent or being compliant with the study procedures.
Any of the following laboratory abnormalities:
Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety.
Participants with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents is acceptable even if parenteral.
Participants unable to swallow tablets, participants with malabsorption syndrome, or any other gastrointestinal disease or gastrointestinal dysfunction that could interfere with absorption of study treatment.
For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR: Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \<60 days or \<14 weeks prior to Cycle 1 Day 1.
Known central nervous system lymphoma or meningeal involvement.
DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, composite lymphoma (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.
Unstable cardiovascular function:
Participants with a BSA \<1.4 m\^2 as calculated per Dubois 1916 or Mosteller 1987.
Any of the following laboratory abnormalities:
Participants who have been committed to an institution by official or judicial order.
Participants with dependency on the Sponsor, Investigator or study site.
Participants with active HBV, HVC, or HIV infections. Participants with active HBV are allowed if antiviral therapy for hepatitis B has been given for \>8 weeks and viral load is \<100 International units per milliliters (IU/mL) prior to first dose of study treatment. Participants 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. Participants with HIV who have CD4+T-cell counts ≥350 cells/microliter (mcL), negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year are allowed.
Known active central nervous system lymphoma or meningeal involvement. Participants with a history of CNS disease treated into remission may be enrolled.
DLBCL with MALT lymphoma, composite lymphoma (Hodgkin's lymphoma + NHL), DLBCL arising from CLL (Richter's transformation), or high-grade B-cell lymphoma.
Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or strong CYP3A inducers ≤14 days prior to Day 1 dosing.
What this trial measures
- Part 1: Overall Response Rate (ORR)One year
Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).
- Part 2: Overall Response Rate (ORR) Based on Lugano CriteriaFrom initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
Assessed according to the response assessment of lymphoma based on Lugano classification.