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

NCT ID: NCT05447260

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2023-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Myelofibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ruxolitinib

Group Type EXPERIMENTAL

Ruxolitinib

Intervention Type DRUG

Dosage based on platelet count

Interventions

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Ruxolitinib

Dosage based on platelet count

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen

Role: CONTACT

18560087023

Yu

Role: CONTACT

Facility Contacts

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Chen

Role: primary

Other Identifiers

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MIPSS70+2.0 MF

Identifier Type: -

Identifier Source: org_study_id

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