A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis

Phase 4

• Conditions: Myelofibrosis
• Interventions: Drug: Ruxolitinib

• Registration Number: NCT05447260
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-10
• Status Verified: 2022-07
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-03
• Last Update Submitted: 2022-07-03
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Primary Completion: 2022-12-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ruxolitinib	Ruxolitinib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China