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OpenTrials
Completed

NCT Number: NCT05410470

Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

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.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Received ruxolitinib treatment for ≥3 months.

Exclusion criteria

  • Malignant tumors with other progression or myelofibrosis secondary to other diseases;
  • Exclude myelofibrosis patients after splenectomy;
  • Patients with poor compliance with case follow-up or lost to follow-up.

Treatment and study plan

Ruxolitinib

Drug

Primary outcomes

  1. The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.

    Time frame: From Week 0 through Week 24

    Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).

Secondary outcomes

  1. The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.

    Time frame: From Week 0 through Week 24

    TSS is assessed by the MPN-10.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2022
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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