Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

Completed

• Conditions: Myelofibrosis
• Interventions: Drug: Ruxolitinib

• Registration Number: NCT05410470
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

Ruxolitinib is a Janus kinase (JAK) 1/2 inhibitor currently used in the treatment of Myelofibrosis (MF). Ruxolitinib confirmed improvements in splenomegaly, MF-related symptoms and survival benefit in COMFORT and JUMP studies. At present, the real-world data on the efficacy and safety of ruxolitinib in the treatment of MF in China is still insufficient. The aim of this study was to evaluate the efficacy and safety of ruxolitinib in patients with MF and to provide guidance for the usage of ruxolitinib in MF in China.This was a retrospective, multicenter study of MF patients who received ruxolitinib treatment in Shandong province from August 2012 to December 2021. Data were analyzed using SPSS. Overall survival (OS) and Event-free survival (EFS) were estimated using the Kaplan- Meier method.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-05
• Last Update Submitted: 2022-06-05
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MF patients who received ruxolitinib treatment	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.