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NCT04562389 · ClinicalTrials.gov registry record · Phase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
A Phase 3 study of Myelofibrosis, sponsored by Karyopharm Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 20
- Study locations
NCT04562389: Active Phase 3 study of Myelofibrosis, sponsored by Karyopharm Therapeutics.
NCT04562389 is a Phase 3 study of Myelofibrosis that is active but no longer recruiting, run by Karyopharm Therapeutics. The registered enrollment target is 353 participants, above the 190-participant average among 61 other Myelofibrosis trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04562389, a Phase 3 study of Myelofibrosis, is active but no longer recruiting, sponsored by Karyopharm Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Selinexor
- DRUG Ruxolitinib
Study Locations (20)
California
- UCLA - Satellite Site - Beverly Hills
- City of Hope - Duarte
- UCLA - Satellite Site - Encino
- City of Hope - Irvine Lennar - Satellite - Irvine
- UCLA - Los Angles
- The Oncology Institute of Hope & Innovation - Pasadena
Maryland
- Maryland Oncology Hematology-Satellite - Annapolis
- The Sidney Kimmel Comprehensive Cancer Center - Baltimore
- Maryland Oncology Hematology-Satellite - Brandywine
- Maryland Oncology Hematology - Columbia
- Maryland Oncology Hematology-Satellite - Rockville
- Maryland Oncology Hematology-Satellite - Silver Spring
Michigan
- The Cancer & Hematology Centers -Satellite Site - Grand Rapids
- The Cancer & Hematology Centers of Muskegon - Norton Shores
Alabama
- UAB Division of Hematology/Oncology - Birmingham
Colorado
- USOR - Rocky Mountain Cancer Centers - Aurora - Aurora
Connecticut
- Smilow Cancer Hospital - New Haven - New Haven
District of Columbia
- Georgetown Lombardi Comprehensive Center - Washington D.C.
Kentucky
- Norton Cancer Institute - Saint Matthews - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2021-03-11 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
What the registry record for NCT04562389 still lists
NCT04562389 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, above the 190-participant average among 61 other Myelofibrosis trials with a reported enrollment target (86% higher).
The record links to 1 condition, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04562389 names 20 study sites across 9 states, led by California, Maryland, Michigan.
Frequently Asked Questions
What is clinical trial NCT04562389 about?
NCT04562389 is a clinical study titled "Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis". 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 compl...
What is the current status of trial NCT04562389?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2021-03-11. Estimated completion is 2028-03.
What conditions does trial NCT04562389 study?
This clinical trial studies the following conditions: Myelofibrosis.
What interventions are being tested in trial NCT04562389?
The interventions under investigation include: Placebo (OTHER), Selinexor (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04562389?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04562389 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelofibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04562389's enrollment target sits among peer trials
353 6th of 61 higher than 56 of 61 other Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
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An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
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A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment
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Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
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