ACTIVE_NOT_RECRUITING

Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.

Official Title

A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Ruxolitinib in Treatment-naïve Patients With Myelofibrosis

Quick Facts

Study Start:2021-03-11
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04562389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged ≥ 18 years
  2. * A diagnosis of primary MF or post-essential thrombocythemia (ET) or postpolycythemia- vera (PV) MF.
  3. * Active symptoms of MF as determined by presence of at least 2 symptoms using the Myelofibrosis Symptom Assessment Form (MFSAF) V4.0.
  4. * Participants with international prognostic scoring system (DIPSS) risk category of intermediate-1, or intermediate-2, or high-risk.
  5. * Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic centimeter (cm\^3) .
  6. * Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 2.
  1. * More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
  2. * Previous treatment with JAK inhibitors for MF.
  3. * Previous treatment with selinexor or other XPO1 inhibitors.

Contacts and Locations

Study Locations (Sites)

UAB Division of Hematology/Oncology
Birmingham, Alabama, 35294
United States
UCLA - Satellite Site
Beverly Hills, California, 90210
United States
City of Hope
Duarte, California, 91010
United States
UCLA - Satellite Site
Encino, California, 93003
United States
City of Hope - Irvine Lennar - Satellite
Irvine, California, 92618
United States
UCLA
Los Angles, California, 90095
United States
The Oncology Institute of Hope & Innovation
Pasadena, California, 91105
United States
USOR - Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80045
United States
Smilow Cancer Hospital - New Haven
New Haven, Connecticut, 06511
United States
Georgetown Lombardi Comprehensive Center
Washington D.C., District of Columbia, 20007
United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, 40207
United States
Maryland Oncology Hematology-Satellite
Annapolis, Maryland, 21401
United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205
United States
Maryland Oncology Hematology-Satellite
Brandywine, Maryland, 21004
United States
Maryland Oncology Hematology
Columbia, Maryland, 21044
United States
Maryland Oncology Hematology-Satellite
Rockville, Maryland, 20850
United States
Maryland Oncology Hematology-Satellite
Silver Spring, Maryland, 20904
United States
The Cancer & Hematology Centers -Satellite Site
Grand Rapids, Michigan, 49546
United States
The Cancer & Hematology Centers of Muskegon
Norton Shores, Michigan, 49444
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Mount Sinai Health System
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke Cancer Institue
Durham, North Carolina, 27705
United States
USOR - Oncology Hematology Care - Kenwood
Cincinnati, Ohio, 45242
United States
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
OhioHealth
Columbus, Ohio, 43214
United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Texas Oncology
Dallas, Texas, 75246
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
USOR - Virginia Cancer Specialists - Gainesville Office
Gainesville, Virginia, 20155
United States
VCU Massey Cancer Center
Richmond, Virginia, 23298
United States
USOR - Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia, 23456
United States
Fred Hutchinson Cancer Center - SCAA South Lake Union
Seattle, Washington, 98109
United States
West Virginia University Cancer Institute, Wheeling Hospital
Wheeling, West Virginia, 26003
United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Karyopharm Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-11
Study Completion Date2028-03

Study Record Updates

Study Start Date2021-03-11
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • Myelofibrosis
  • Selinexor
  • Ruxolitinib
  • Janus kinase 2
  • Myeloproliferative neoplasms

Additional Relevant MeSH Terms

  • Myelofibrosis