Efficacy and Safety of Ruxolitinib in Patients With Myelo... | NCT05410470

Studies
Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis

NCT05410470

Sponsor

Qilu Hospital of Shandong University

Status

Completed

Last Update Posted

Jun 8, 2022Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Myelofibrosis

Interventions

Ruxolitinib

Countries

Not provided

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012Actual

Primary Completion Date

Dec 2021Actual

Completion Date

Dec 2021Actual

First Submitted Date

May 23, 2022

First Submission Date that Met QC Criteria

Jun 5, 2022

First Posted Date

Jun 8, 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

Jun 5, 2022

Last Update Posted Date

Jun 8, 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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ruxolitinib is a Janus kinase (JAK) 1/2 inhibitor currently used in the treatment of Myelofibrosis (MF). Ruxolitinib confirmed improvements in splenomegaly, MF-related symptoms and survival benefit in COMFORT and JUMP studies. At present, the real-world data on the efficacy and safety of ruxolitinib in the treatment of MF in China is still insufficient. The aim of this study was to evaluate the efficacy and safety of ruxolitinib in patients with MF and to provide guidance for the usage of ruxolitinib in MF in China.This was a retrospective, multicenter study of MF patients who received ruxolitinib treatment in Shandong province from August 2012 to December 2021. Data were analyzed using SPSS. Overall survival (OS) and Event-free survival (EFS) were estimated using the Kaplan- Meier method.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Label	Type	Description	Intervention Names
MF patients who received ruxolitinib treatment			Drug: Ruxolitinib

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib	Drug		MF patients who received ruxolitinib treatment

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

MF patients including primary and secondary MF patients who received ruxolitinib treatment are going to be recruited.

Sampling Method

Probability Sample

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