Study on Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or Without Selinexor for Patients with Relapsed or Hard-to-Treat Diffuse Large B-cell Lymphoma

Sponsor: Karyopharm Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04442022

Provider View

This clinical trial is testing a new treatment combination for patients with Diffuse Large B-cell Lymphoma (DLBCL) that has returned or is not responding to treatment. The study will compare the effects of adding the drug selinexor to the standard R-GDP treatment.

Patient Parameters

Program Overview

The study aims to find out if adding selinexor to the standard R-GDP treatment can help patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) who are not eligible for stem cell or CAR-T cell therapy. The trial will have two phases. In Phase 2, different doses of selinexor will be tested with R-GDP to see which is most effective. In Phase 3, the best dose from Phase 2 will be compared to the standard R-GDP treatment to see if it works better. Patients who respond well to the treatment will continue with selinexor or a placebo alone.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) or DLBCL that has changed from a slower-growing lymphoma.
  • Have received 1 to 3 previous treatments for DLBCL that did not work or the cancer came back.
  • Have a PET scan showing at least one tumor that can be measured.
  • Not planning to have stem cell or CAR-T cell therapy.
  • Have good bone marrow, liver, and kidney function based on blood tests.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have a life expectancy of more than 3 months.
  • Agree to use effective birth control during the study and for 12 months after the last treatment.
  • Women must have a negative pregnancy test before starting the study.
  • Men must agree not to donate sperm during the study and for 12 months after the last treatment.

Exclusion Criteria

  • Have certain types of lymphoma not included in the study.
  • Have been treated with selinexor or similar drugs before.
  • Have allergies to any drugs in the study treatment.
  • Have active cancer in the brain or spinal cord.
  • Have had other cancer treatments within 21 days before starting the study.
  • Have not recovered from side effects of previous cancer treatments.
  • Have had major surgery within 14 days before starting the study.
  • Have had recent stem cell or CAR-T cell therapy.
  • Have severe nerve damage.
  • Have serious health conditions that could affect safety or study participation.
  • Have uncontrolled infections or certain viral infections.
  • Cannot swallow pills or have digestive issues affecting drug absorption.
  • Are pregnant or breastfeeding.
  • Cannot or do not want to sign the consent form.
  • Are significantly underweight according to the study doctor.
  • Have received a live vaccine within 28 days before starting the study.

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