Study of Selinexor Combined with Ruxolitinib for Myelofibrosis

Sponsor: Karyopharm Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04562389

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combining selinexor and ruxolitinib for patients with myelofibrosis who have not previously been treated with JAK inhibitors.

Patient Parameters

Program Overview

This study is being conducted worldwide to evaluate how well the combination of selinexor and ruxolitinib works and how safe it is for patients with myelofibrosis who have not been treated with JAK inhibitors before. The study has two parts: Phase 1, which has already been completed, focused on finding a safe dose of the drug combination. Phase 3, which is ongoing, is comparing the effects of the selinexor and ruxolitinib combination to a placebo and ruxolitinib combination.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary myelofibrosis (MF) or MF that developed after essential thrombocythemia (ET) or polycythemia vera (PV).
  • Enlarged spleen as shown by a scan, with a volume of at least 450 cubic centimeters.
  • Intermediate-1, intermediate-2, or high-risk category according to a specific scoring system.
  • Aged 18 years or older.
  • Good overall health with a performance status score of 0 to 2.
  • Platelet count of at least 100 billion per liter without needing a transfusion.
  • Neutrophil count of at least 1 billion per liter without needing growth factors.
  • Adequate liver function based on specific blood tests.
  • Kidney function with creatinine clearance over 15 mL/min.
  • If you have hepatitis B, you must have been on antiviral treatment for over 8 weeks with a low viral load.
  • If you have a history of hepatitis C, you must have completed treatment and have a low viral load.
  • If you have HIV, you must have a CD4+ T-cell count of at least 350, a negative viral load, and no serious infections in the past year, and be on antiretroviral therapy for at least 4 weeks.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after treatment.
  • Men must use a barrier method of contraception and agree not to donate sperm during and after treatment.
  • Must sign a consent form agreeing to participate.
  • Must have active symptoms of MF as determined by a specific assessment form.
  • Not eligible for stem cell transplantation.
  • Must provide bone marrow biopsy samples.
  • Life expectancy of more than 6 months.
  • No other cancers within the past 2 years, except for certain treated skin, breast, or prostate cancers.

Exclusion Criteria

  • More than 10% blasts in blood or bone marrow.
  • Previous treatment with JAK inhibitors or selinexor.
  • Gastrointestinal issues that affect drug absorption.
  • Recent use of certain medications that affect drug metabolism.
  • Major surgery within the past 28 days.
  • Uncontrolled infection requiring strong medication.
  • Any serious illness or condition that could affect safety or study results.
  • Pregnant or breastfeeding women.
  • Prior spleen surgery or treatment within the past 6 months.
  • Unable to undergo required scans.
  • Allergies to study drugs.
  • History of certain heart or lung conditions.
  • Unable to tolerate anti-nausea medications.

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