A phase 2, randomized, open-label, multicenter study to evaluate safety and efficacy of single agent selinexor versus treatment of physician’s choice in patients with previously treated myelofibrosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513605-31-00

Acronym

XPORT-MF-035

Enrollment

Registered

2024-10-25

Start date

2021-10-21

Completion date

Unknown

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Brief summary

Rate of Spleen Volume Reduction of > or = 35% (SVR35)

Detailed description

Rate of Total Symptom Score reduction of > or = 50% (TSS50) in the myelofibrosis symptom assessment form (MFSAF) V4.0, based on local assessment, Rate of Spleen Volume Reduction of > or =25% (SVR25), Overall survival (OS), Anemia response as defined per the IWG-MRT criteria, based on local assessment • Duration of SVR35 and SVR25 • Duration of TSS50 based on local assessment • ORR (Complete Response [CR] + Partial Response [PR] + Clinical Improvement [CI]) by IWG-MRT criteria, based on local assessment, The occurrence, nature, and severity of AEs, Population PK derived parameters: • AUC • Cmax

Interventions

DRUGSELINEXOR

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Secondary

Measure	Time frame
Rate of Total Symptom Score reduction of > or = 50% (TSS50) in the myelofibrosis symptom assessment form (MFSAF) V4.0, based on local assessment, Rate of Spleen Volume Reduction of > or =25% (SVR25), Overall survival (OS), Anemia response as defined per the IWG-MRT criteria, based on local assessment • Duration of SVR35 and SVR25 • Duration of TSS50 based on local assessment • ORR (Complete Response [CR] + Partial Response [PR] + Clinical Improvement [CI]) by IWG-MRT criteria, based on local assessment, The occurrence, nature, and severity of AEs, Population PK derived parameters: • AUC • Cmax	—

Measure

Time frame

—

Primary

Measure	Time frame
Rate of Spleen Volume Reduction of > or = 35% (SVR35)	—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026