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

Official Title

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)

Summary:

Randomized two-arm, multicentre, open-label Phase 2b study of 2 doses of selinexor (KPT-330) in patients with relapsed/refractory de novo DLBCL who have no therapeutic options of demonstrated clinical benefit.

Trial Description

Primary Outcome:

  • Objective Response
This is a randomized two-arm, multicentre, open-label Phase 2b study of the SINE selinexor high and selinexor low doses given orally to patients with relapsed/refractory de novo DLBCL who have no therapeutic options of demonstrated clinical benefit. Two hundred patients (100 per arm) with relapsed/refractory de novo 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 randomized in a 1:1 ratio of high (100 mg) to low (60 mg) selinexor doses. Enrolled patients will take a fixed milligram dose of selinexor orally twice weekly. Patients will be followed until disease progression and death.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society