A New Prognostic Stratification-based Safety and Efficacy... | NCT05447260

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

NCT05447260

Sponsor

Qilu Hospital of Shandong University

Status

Unknown status

Last Update Posted

Jul 7, 2022Actual

Enrollment

87Estimated

Phase

Phase 4

Conditions

Myelofibrosis

Interventions

Ruxolitinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2022Actual

Primary Completion Date

Dec 10, 2022Estimated

Completion Date

Dec 10, 2023Estimated

First Submitted Date

Jul 3, 2022

First Submission Date that Met QC Criteria

Jul 3, 2022

First Posted Date

Jul 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2022

Last Update Posted Date

Jul 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ruxolitinib	Experimental		Drug: Ruxolitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib	Drug	Dosage based on platelet count	Ruxolitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.	TSS is assessed by the MPN-10.	From Week 0 through Week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen	Contact	18560087023		chency@sdu.edu.cn
Yu	Contact			yuyuandoctor@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University	Recruiting	Jinan	Shandong		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055728	Primary Myelofibrosis

Ancestor Terms

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C540383	ruxolitinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided