A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
Study Details
Study Description
Brief Summary
This is a multi-center, prospective, single-arm study to assess safety and efficacy of Ruxolitinib in myelofibrosis (MF) based on a new prognostic stratification.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Ruxolitinib
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Drug: Ruxolitinib
Dosage based on platelet count
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Outcome Measures
Primary Outcome Measures
- The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline. [From Week 0 through Week 24]
Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).
Secondary Outcome Measures
- The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline. [From Week 0 through Week 24]
TSS is assessed by the MPN-10.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients aged ≥18 years with a diagnosis of primary or secondary MF by World Health Organization and International Working Group for Myeloproliferative Neoplasms Research and Treat- ment (IWG-MRT) criteria;
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Received ruxolitinib treatment for ≥3 months.
Exclusion Criteria:
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Malignant tumors with other progression or myelofibrosis secondary to other diseases;
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Exclude myelofibrosis patients after splenectomy;
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Patients with poor compliance with case follow-up or lost to follow-up.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Qilu Hospital of Shandong University | Jinan | Shandong | China |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIPSS70+2.0 MF