Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05410470

Enrollment

130

Registered

2022-06-08

Start date

2012-08-31

Completion date

2021-12-31

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

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.

Interventions

DRUGRuxolitinib

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026