---
title: A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
nct_id: NCT05447260
overall_status: UNKNOWN
phase: PHASE4
sponsor: Qilu Hospital of Shandong University
study_type: INTERVENTIONAL
primary_condition: Myelofibrosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05447260.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05447260"
ct_last_update_post_date: 2022-07-07
last_seen_at: "2026-05-12T06:09:53.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05447260](https://clinicaltrials.gov/study/NCT05447260)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 87
- **Lead Sponsor:** Qilu Hospital of Shandong University
- **Conditions:** Myelofibrosis
- **Start Date:** 2022-06-10
- **Completion Date:** 2023-12-10
- **CT.gov Last Update:** 2022-07-07

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Ruxolitinib** (EXPERIMENTAL)

## Interventions

- **Ruxolitinib** (DRUG) — Dosage based on platelet count

## Primary Outcomes

- **The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.** _(time frame: From Week 0 through Week 24)_ — Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).

## Secondary Outcomes

- **The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.** _(time frame: From Week 0 through Week 24)_

## Locations (1)

- Qilu Hospital of Shandong University, Jinan, Shandong, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.qilu hospital of shandong university|jinan|shandong|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05447260*  
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