A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- Interventional
- Active
- NCT02227251
Contact Information
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
- 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