Study on Selinexor with Chemotherapy for Treating Advanced B Cell Non-Hodgkin Lymphoma

Sponsor: Barbara Ann Karmanos Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03147885

Provider View

This clinical trial is testing a new treatment that combines the drug Selinexor with standard chemotherapy to see if it can better treat patients with advanced B cell Non-Hodgkin Lymphoma. The study aims to find the best dose and evaluate the effectiveness of this combination therapy.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for advanced B cell Non-Hodgkin Lymphoma by combining Selinexor, a drug that targets cancer cells, with standard chemotherapy known as R-CHOP. The trial is divided into two phases. Phase 1B will determine the safest and most effective dose of Selinexor when used with R-CHOP. Phase 2 will test this dose in patients with newly diagnosed diffuse large B cell lymphoma (DLBCL) to see if it improves survival without the cancer progressing over two years. Patients who respond well to the treatment may continue taking Selinexor for maintenance therapy for up to one year.

Description

The study consists of two parts: Phase 1B and Phase 2.

In Phase 1B, researchers will enroll patients to find the best dose of Selinexor when combined with R-CHOP chemotherapy. This phase includes patients with newly diagnosed or relapsed indolent and diffuse large cell lymphomas. The goal is to establish the recommended dose for Phase 2.

In Phase 2, the established dose from Phase 1B will be used to treat patients with newly diagnosed diffuse large B cell lymphoma (DLBCL). The main focus is to see if this treatment can help patients live longer without the cancer getting worse over two years.

For patients with Follicular Lymphoma and Diffuse Large B cell lymphoma who show a partial response or better, a maintenance phase with Selinexor will be offered for one year, using the same dose as in the treatment phase.

Eligibility Criteria

Inclusion Criteria

  • Phase 1: Patients with advanced stage B-cell Non-Hodgkin Lymphoma (stage 3 or 4) for whom R-CHOP is suitable. This includes newly diagnosed DLBCL, low grade B cell NHL, and those in first relapse after non-anthracycline chemotherapy.
  • Phase 2: Patients with newly diagnosed diffuse large B cell lymphoma (stage 3 or 4).
  • Must have measurable disease, with at least one lesion above and below the diaphragm or stage 4 disease measurable in one dimension.
  • Allowed prior therapy:
    • Newly diagnosed DLBCL and low grade B cell lymphoma: No prior therapy except up to one week of steroids.
    • Relapsed/refractory low grade B cell lymphoma: One prior non-anthracycline therapy allowed.
  • All races and ethnic groups are eligible.
  • ECOG performance status of 0 or 1.
  • Life expectancy greater than 6 months.
  • Women of child-bearing potential must use dual contraception and have a negative pregnancy test; men must use effective contraception.
  • Ability to understand and sign informed consent.

Exclusion Criteria

  • Patients with DLBCL who have had prior chemotherapy or immunotherapy (except one week of steroids).
  • Patients with low grade B cell lymphomas who have had more than one prior line of chemotherapy or any anthracycline therapy.
  • Patients on other investigational drugs.
  • Patients with known brain metastases.
  • History of severe allergic reactions to study drugs.
  • Uncontrolled illnesses like active infections, severe heart conditions, or psychiatric issues.
  • Pregnant or breastfeeding women.
  • HIV-positive patients or those with active hepatitis B or C.
  • Severe intolerance to glucocorticoids.
  • Major surgery within two weeks of starting the study.
  • Inability to swallow tablets or gastrointestinal issues affecting drug absorption.
  • Low blood cell counts or abnormal liver/kidney function tests.

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