A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

  • Interventional
  • Not Recruiting
  • NCT02227251
Eligibility Details Visit Clinicaltrials.gov

Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A multicenter, open-label Phase 2b study of selinexor (KPT-330) in patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit.

This is a multicenter, open-label Phase 2b study of the SINE compound, selinexor. A fixed 60 mg dose of selinexor is given orally to patients with relapsed/refractory DLBCL who have no therapeutic options of demonstrated clinical benefit. One hundred thirty patients with relapsed/refractory DLBCL who meet eligibility criteria and have none of the exclusion criteria will be enrolled to receive selinexor until either disease progression or intolerance has occurred. Patients will be followed until disease progression and/or death.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Age ≥18 years

         - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

         - Pathologically confirmed de novo DLBCL

         - Objective, documented evidence of disease progression on study entry

         - Have previously received at least 2 but no more than 5 previous systemic regimens for the treatment of DLBCL

         - Have measurable disease

         - For patients whose most recent anti-DLBCL therapy induced a PR or CR, at least 60 days must have elapsed since the end of that therapy. For all other patients, at least 14 weeks must have elapsed since their most recent systemic anti-DLBCL therapy

        Exclusion Criteria:

         - DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (HL+NHL) or DLBCL transformed from diseases other than indolent NHL

         - Must not be eligible for high-dose therapy with autologous stem cell transplantation rescue

         - Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

         - Known central nervous system (CNS) lymphoma

         - Active Hepatitis B or C infection

         - Known human immunodeficiency virus (HIV) infection

         - Unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI function that could interfere with absorption of study treatment

At a Glance

National Government IDNCT02227251

IRB#IRB14-1042

Lead SponsorKaryopharm Therapeutics Inc

Lead PhysicianSonali Smith

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting