NCT05447260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 3, 2022

Last Update Submit

July 3, 2022

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)

Ruxolitinib

EXPERIMENTAL
Drug: Ruxolitinib

Interventions

RuxolitinibDRUG

Dosage based on platelet count

Ruxolitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Chen

CONTACT

18560087023chency@sdu.edu.cn

Yu

CONTACT

yuyuandoctor@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

June 10, 2022

Primary Completion

December 10, 2022

Study Completion

December 10, 2023

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

CN(1)