Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis (NCT04562389)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB Division of Hematology/Oncology — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (166 Sites)
Showing the first 25 of 166 sites.
- UAB Division of Hematology/Oncology — Birmingham, Alabama
- UCLA - Satellite Site — Beverly Hills, California
- City of Hope — Duarte, California
- UCLA - Satellite Site — Encino, California
- City of Hope - Irvine Lennar - Satellite — Irvine, California
- UCLA — Los Angles, California
- The Oncology Institute of Hope & Innovation — Pasadena, California
- USOR - Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado
- Smilow Cancer Hospital - New Haven — New Haven, Connecticut
- Georgetown Lombardi Comprehensive Center — Washington D.C., District of Columbia
- Norton Cancer Institute - Saint Matthews — Louisville, Kentucky
- Maryland Oncology Hematology-Satellite — Annapolis, Maryland
- The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland
- Maryland Oncology Hematology-Satellite — Brandywine, Maryland
- Maryland Oncology Hematology — Columbia, Maryland
- Maryland Oncology Hematology-Satellite — Rockville, Maryland
- Maryland Oncology Hematology-Satellite — Silver Spring, Maryland
- The Cancer & Hematology Centers -Satellite Site — Grand Rapids, Michigan
- The Cancer & Hematology Centers of Muskegon — Norton Shores, Michigan
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey
- Mount Sinai Health System — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Duke Cancer Institue — Durham, North Carolina
- USOR - Oncology Hematology Care - Kenwood — Cincinnati, Ohio
- Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute — Columbus, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Myelofibrosis
- Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms — Birmingham, Alabama
- Study of Stem Cell Transplant vs. Non-Transplant Therapies in High-Risk Myelofibrosis — Calgary, Alberta
- Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) — Birmingham, Alabama
- A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis — Pasadena, California
- A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) — Newport Beach, California
Explore by condition: All Myelofibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.