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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Molecular analysis
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myelofibrosis, Primary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Primary Myelofibrosis

Secondary Myelofibrosis

Arm Description

Blood test

Blood test

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 11, 2018
Last Updated
July 2, 2019
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03402399
Brief Title
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
Acronym
MRMF01
Official Title
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
December 9, 2019 (Anticipated)
Study Completion Date
December 9, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification Age ≥ 18 years 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis, Primary, Myelofibrosis, Post PV, Myelofibrosis, Post ET

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary Myelofibrosis
Arm Type
Other
Arm Description
Blood test
Arm Title
Secondary Myelofibrosis
Arm Type
Other
Arm Description
Blood test
Intervention Type
Other
Intervention Name(s)
Molecular analysis
Intervention Description
Blood test
Primary Outcome Measure Information:
Title
Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF
Description
Proportions of patients with HMR mutations in each arm
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification Age . 18 years Patient is willing and capable of giving a written informed consent. Concurrent participation in clinical trials will be allowed Exclusion Criteria: Unwilling or unable to provide informed consent Prefibrotic MF
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirly Broitman
Phone
+972-8-9778452
Email
shirlib@asaf.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Koren-Michowitz, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Koren-Michowitz, MD
Email
korenm@asaf.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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