CTIS2023-506139-13-00
Recruiting
Phase 1
A PHASE 1/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR, A SELECTIVE INHIBITOR OF NUCLEAR EXPORT, IN COMBINATION WITH RUXOLITINIB IN TREATMENT-NAÏVE PATIENTS WITH MYELOFIBROSIS - XPORT-MF-034
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment naïve patients with MF
- Sponsor
- Karyopharm Therapeutics Inc.
- Enrollment
- 304
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Spleen volume of \=450 cm3 by MRI or CT scan., DIPSS risk category of intermediate\-1, or intermediate\-2, or high\-risk., ECOG Performance Status \=2\., Platelet count \=100 × 109/L without platelet transfusion., Active symptoms of MF as determined by presence of at least 2 symptoms with a score \=3 or total score of \=10 at screening using the MFSAF V4\.0\.
Exclusion Criteria
- •Previous treatment with JAK inhibitors for MF., More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase).
Outcomes
Primary Outcomes
Not specified
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