Myelofibrosis
Conditions
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.
Interventions
DRUGRuxolitinib
Dosage based on platelet count
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Received ruxolitinib treatment for ≥3 months.
Exclusion criteria
1. Malignant tumors with other progression or myelofibrosis secondary to other diseases; 2. Exclude myelofibrosis patients after splenectomy; 3. Patients with poor compliance with case follow-up or lost to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactChen
Backup ContactYu
Outcome results
None listed