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

Myelofibrosis, Post ET Clinical Trial

— MRMF01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402399
• Other study ID #: 0124-17
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: December 9, 2020

Study information

• Verified date: July 2019
• Source: Assaf-Harofeh Medical Center
• Contact: Shirly Broitman
• Phone: +972-8-9778452
• Email: shirlib[@]asaf.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelofibrosis, Post ET
• Myelofibrosis, Post PV
• Myelofibrosis, Primary
• Primary Myelofibrosis

Intervention

Other:
• Molecular analysis
Blood test

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF	Proportions of patients with HMR mutations in each arm	Baseline