Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

Myelofibrosis Clinical Trial

Official title:

Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis: A Retrospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410470
• Other study ID #: QiluH MF
• Status: Completed
• Start date: August 2012
• Est. completion date: December 2021

Study information

• Verified date: May 2022
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Intervention

Drug:
• Ruxolitinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with a =35% reduction in palpable spleen volume from baseline.	Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).	From Week 0 through Week 24
Secondary	The proportion of patients with =50% reduction in Total Symptom Score (TSS) from baseline.	TSS is assessed by the MPN-10.	From Week 0 through Week 24