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

Qilu Hospital of Shandong University87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelofibrosis

Interventions

RuxolitinibDRUG

Dosage based on platelet count

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: From Week 0 through Week 24

Secondary Outcomes

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

TSS is assessed by the MPN-10.

Time frame: From Week 0 through Week 24

Central Contacts

Chen

CONTACT

18560087023 chency@sdu.edu.cn

CONTACT

yuyuandoctor@163.com

Data from ClinicalTrials.gov

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