A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis

Myelofibrosis Clinical Trial

Official title:

A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis: a Multicenter, Prospective, Single-arm Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447260
• Other study ID #: MIPSS70+2.0 MF
• Status: Recruiting
• Phase: Phase 4
• Start date: June 10, 2022
• Est. completion date: December 10, 2023

Study information

• Verified date: July 2022
• Source: Qilu Hospital of Shandong University
• Contact: Chen
• Phone: 18560087023
• Email: chency[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, prospective, single-arm study to assess safety and efficacy of Ruxolitinib in myelofibrosis (MF) based on a new prognostic stratification.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2022
• 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
Dosage based on platelet count

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

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