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Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Completed
CT.gov ID
NCT05410470
Collaborator
(none)
130
Enrollment
112
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
130 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis: A Retrospective Multicenter Study
Actual Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
MF patients who received ruxolitinib treatment

Drug: Ruxolitinib

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05410470
Other Study ID Numbers:
  • QiluH MF
First Posted:
Jun 8, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Primary Myelofibrosis

Study Results

No Results Posted as of Jun 8, 2022