Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

NCT05410470 | Completed FDA Drug

• 1 other identifier: QiluH MF
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  From Week 0 through Week 24

Study Arms (1)

MF patients who received ruxolitinib treatment

Drug: Ruxolitinib

Interventions

Ruxolitinib DRUG

MF patients who received ruxolitinib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MF patients including primary and secondary MF patients who received ruxolitinib treatment are going to be recruited.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 8, 2022
• Study Start: August 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 8, 2022

Record last verified: 2022-05