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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05447260
Collaborator
(none)
87
1
1
18
4.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
87 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis: a Multicenter, Prospective, Single-arm Clinical Study
Actual Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
Dec 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruxolitinib

Drug: Ruxolitinib
Dosage based on platelet count

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

Site City State Country Postal Code
1 Qilu Hospital of Shandong University Jinan Shandong China

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:
NCT05447260
Other Study ID Numbers:
  • MIPSS70+2.0 MF
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022