Study on Selinexor for Patients with Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor: Karyopharm Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02227251

Provider View

This clinical trial is testing the drug Selinexor in patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or is not responding to treatment. The study aims to find out if Selinexor can help these patients when other treatments have not worked.

Patient Parameters

Program Overview

This study is exploring the use of Selinexor, a drug taken by mouth, in patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has come back or is not responding to other treatments. The trial is divided into two parts. In the first part, all participants will receive a fixed dose of Selinexor. In the second part, participants will be randomly assigned to receive one of two different doses of Selinexor. The study will monitor participants until their disease progresses or they can no longer tolerate the treatment.

Description

This clinical trial is testing Selinexor, a drug that works by blocking certain proteins in cancer cells, in patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or is not responding to treatment. The study is open-label, meaning both the researchers and participants know what treatment is being given. It is conducted in two parts:

  • Part 1: All participants will receive a 60 mg dose of Selinexor. The study will include 130 participants who have no other treatment options that have shown benefits. Participants will continue taking Selinexor until their disease worsens or they experience intolerable side effects.

  • Part 2: Approximately 110 participants will be divided into two groups. One group will receive a 40 mg dose, and the other will receive a 60 mg dose of Selinexor. Participants will be grouped based on whether they have had a stem cell transplant before. The study will continue until the disease progresses or the participant can no longer tolerate the treatment.

Participants will be closely monitored throughout the study to assess the drug's effectiveness and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must have had a partial or complete response to their last DLBCL treatment, with at least 60 days since that treatment ended. For others, at least 14 weeks must have passed since their last treatment.
  • Must have evidence of DLBCL progression before starting the study.
  • Must have measurable disease based on specific criteria for lymphoma.
  • Must have adequate blood cell counts and organ function.
  • For Part 2, at least 3 weeks must have passed since the last DLBCL treatment before starting the study.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have primary mediastinal large B-cell lymphoma.
  • Cannot be eligible for high-dose chemotherapy with stem cell rescue.
  • Cannot have unresolved side effects from previous treatments.
  • Cannot have had major surgery within 2 weeks of starting the study.
  • Cannot have active hepatitis B, C, or HIV infections.
  • Cannot have psychiatric or substance use issues that prevent understanding the study.
  • Cannot have certain blood or organ function abnormalities.
  • Cannot have active graft-versus-host disease after stem cell transplant.
  • Cannot have uncontrolled infections requiring IV treatment.
  • Cannot have conditions that prevent swallowing tablets or absorbing the drug.
  • Cannot have certain types of DLBCL or unstable heart conditions.
  • Cannot have a body surface area less than 1.4 m².
  • Cannot have been committed to an institution by legal order or be dependent on the study team.

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