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

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Myelofibrosis, Primary; Myelofibrosis, Post PV; Myelofibrosis, Post ET

Treatments: Other: Molecular analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03402399

0124-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Primary Myelofibrosis

Other group

Description:

Blood test

Treatment:

Other: Molecular analysis

Secondary Myelofibrosis

Other group

Description:

Blood test

Treatment:

Other: Molecular analysis