Back to resultsA New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
Primary Purpose
Myelofibrosis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis
Eligibility Criteria
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.
Sites / Locations
- Qilu Hospital of Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ruxolitinib
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.
TSS is assessed by the MPN-10.
Full Information
NCT ID
NCT05447260
First Posted
July 3, 2022
Last Updated
July 3, 2022
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05447260
Brief Title
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
Official Title
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis: a Multicenter, Prospective, Single-arm Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Intervention Description
Dosage based on platelet count
Primary Outcome Measure Information:
Title
The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.
Description
Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).
Time Frame
From Week 0 through Week 24
Secondary Outcome Measure Information:
Title
The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.
Description
TSS is assessed by the MPN-10.
Time Frame
From Week 0 through Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen
Phone
18560087023
Email
chency@sdu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu
Email
yuyuandoctor@163.com
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen
Email
chency@sdu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
We'll reach out to this number within 24 hrs