Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis

Not Applicable

• Conditions: Myelofibrosis, Post PV; Myelofibrosis, Post ET; Myelofibrosis, Primary
• Interventions: Other: Molecular analysis

• Registration Number: NCT03402399
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post PV/ET) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.

Detailed Description

Main inclusion criteria:

1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification

2. Age ≥ 18 years

3. Concurrent participation in clinical trials will be allowed.

Efficacy assessments will be evaluated by: HMR mutations rate, specific HMR mutations, disease duration, presence of splenomegaly, cytogenetic risk, DIPPS, IPSS, ET survival score and PV survival score.

The primary efficacy parameter to be assessed will be HMR mutation rate.

Study Timeline

• Study Start: 2017-12-10
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2019-12-09
• Study Completion: 2020-12-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
2. Age . 18 years
3. Patient is willing and capable of giving a written informed consent.
4. Concurrent participation in clinical trials will be allowed

Exclusion Criteria

1. Unwilling or unable to provide informed consent
2. Prefibrotic MF

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary Myelofibrosis	Molecular analysis	Blood test
Primary Myelofibrosis	Molecular analysis	Blood test

Primary Outcome Measures

Name	Time	Method
Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF	Baseline	Proportions of patients with HMR mutations in each arm

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel