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 (NCT04576156)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Diagnosis of primary myelofibrosis according to the revised World Health Organization criteria or post-essential thrombocythemia-MF or post-polycythemia vera-MF according to the IWG-MRT criteria
2. Dynamic International Prognostic Scoring System intermediate-2 or high-risk MF
3. Relapsed/refractory to JAK-inhibitor treatment as defined in either inclusion (i), (ii) or (iii) and not eligible for allogeneic stem cell transplantation (ASCT) at screening:
4. (i) Treatment with JAK-inhibitor for \>= 6 months duration, including at least 2 months at an optimal dose as assessed by the investigator for that participant and at least one of the following:
5. no decrease in spleen volume (\< 10% by MRI or CT) from the start of treatment with JAK-inhibitor
6. no decrease in spleen size (\< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor
7. no decrease in symptoms (\< 20% by Myelofibrosis Symptom Assessment Form \[MFSAF\] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor
8. a score of at least 15 on TSS assessed using the MFSAF v4.0 during screening.
9. (ii) Treatment with JAK-inhibitor treatment for\>= 3 months duration with maximal doses (e.g., 20-25 mg twice daily ruxolitinib) for that participant and no decrease in spleen volume/size or symptoms as defined in inclusion criterion (i \[a, b, or c\]).
10. (iii) Following maximum tolerated doses of JAK inhibitor therapy for ≥3 months duration, having documented relapsed disease defined as either
11. Increase in spleen volume from time of best response by 25% measured by MRI or CT, or
12. Increase in spleen size by palpation, CT, or ultrasound

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (144 Sites)

• University of California-San Diego/Moores UCSD Cancer Center — La Jolla, California
• UCLA David Geffen School of Medicine — Los Angeles, California
• Smilow Cancer Center at YNHH — New Haven, Connecticut
• BRCR Medical Center Inc — Plantation, Florida
• University of South Florida — Tampa, Florida
• Norton Cancer Institute — Louisville, Kentucky
• Icahn School of Medicine at Mount Sinai — New York, New York
• Duke University Medical Center — Durham, North Carolina
• Gabrail Cancer Center — Canton, Ohio
• Prairie Lakes Health Care System, Inc. — Watertown, South Dakota
• The University of Texas MD — Houston, Texas
• Northwest Medical Specialties PLLC — Seattle, Washington
• Hospital Aleman — Ciudad de Buenos Aires, Buenos Aires
• Sanatorio de la Mujer — Rosario, Santa Fe Province
• Sanatorio Allende — Córdoba,
• Royal North Shore Hospital — St Leonards, New South Wales
• Royal Brisbane and Women's Hospital — Herston, Queensland
• Royal Hobart Hospital — Hobart, Tasmania
• Epworth Healthcare — Richmond, Victoria
• Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel — Wein, Burgenland
• Krankenhaus der Elisabethinen — Linz, Upper Austria
• Kepler Universitätsklinikum Gm — Linz, Upper Austria
• Klinikum Wels-Grieskirchen GmbH — Wels, Upper Austria
• AZ Klina — Antwerp, Antwerpen
• UZ Antwerpen — Edegem, Antwerpen

💰 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.