Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis (MRMF01)

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.

Study Overview

• Status: Unknown
• Conditions: Myelofibrosis, Primary; Myelofibrosis, Post PV; Myelofibrosis, Post ET
• Intervention / Treatment: Other: Molecular analysis

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 Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel
    • Recruiting
    • Assaf Harofeh Medical Center
    • Contact: Maya Koren-Michowitz, MD; Email: korenm@asaf.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Primary Myelofibrosis; Blood test	Other: Molecular analysis; Blood test
Other: Secondary Myelofibrosis; Blood test	Other: Molecular analysis; Blood test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Maya Koren-Michowitz, MD, Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2017
• Primary Completion (Anticipated): December 9, 2019
• Study Completion (Anticipated): December 9, 2020

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Primary Myelofibrosis
• Other Study ID Numbers: 0124-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No