A Phase 2b Open-label, Randomized, Two-arm Study comparing high and low doses of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 1

• Conditions: Relapsed/Refractory DLBCL; MedDRA version: 18.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001977-15-IT
• Lead Sponsor: Karyopharm Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-07
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients, age = 18 years, with pathologically confirmed DLBCL whose disease is relapsed and/or refractory, with documented evidence of disease progression after the most recently administered chemotherapy regimen (according to International Working Group (IWG) criteria for progression of lymphoma, Cheson 2007), and who in the opinion of the investigator are not candidates for high-dose chemotherapy with autologous stem cell rescue, may be considered for enrollment. Patients must have received at least 2 but no more than 4 previous systemic regimens for the treatment of their DLBCL including at least one 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 at least one course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Patients who were considered ineligible for standard multi-agent immunochemotherapy must have received at least two (and no more than four) prior treatment regimens including at least one 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. Patients should have an estimated life expectancy of more than 3 months at study entry. DLBCL histology, DLBCL subtype (GCB or non-GCB) as well as DH-DLBCL status will be confirmed/determined in all patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Patients with histologies other than de novo DLBCL, (i.e., patients with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma (PMBL), or active central nervous system (CNS) lymphoma, will be excluded from this study. Patients with CD20 negative DLBCL are also excluded. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation and documentation for ineligibility must be provided.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified