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

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03402399
• Collaborator: (none)
• Enrollment: 222
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 6.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelofibrosis, Primary; Myelofibrosis, Post PV; Myelofibrosis, Post ET	Other: Molecular analysis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 222 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
• Actual Study Start Date: Dec 10, 2017
• Anticipated Primary Completion Date: Dec 9, 2019
• Anticipated Study Completion Date: Dec 9, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assaf Harofeh Medical Center	Zerifin		Israel

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assaf-Harofeh Medical Center
• ClinicalTrials.gov Identifier: NCT03402399
• Other Study ID Numbers: 0124-17
• First Posted: Jan 18, 2018
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Primary Myelofibrosis

Study Results

No Results Posted as of Jul 5, 2019