Myelofibrosis, PrimaryMRMF01NCT03402399
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
A study testing Molecular analysis in people with Myelofibrosis, Primary and Myelofibrosis, Post PV, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Primary, Myelofibrosis, Post PV, Myelofibrosis, Post ET
- What is being tested?
- Molecular analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Dec 2017to 9 Dec 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide informed consent
- Prefibrotic MF
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Ẕerifin
Maya Koren-Michowitz, MD, korenm@asaf.health.gov.il
About this study
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.
Read the 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.
- Being tested
- Molecular analysis
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular analysisOther
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Primary Myelofibrosis | Other | Blood test Receives: Other: Molecular analysis |
| Secondary Myelofibrosis | Other | Blood test Receives: Other: Molecular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start10 Dec 2017
- Primary completion9 Dec 2019 (estimated)
- Study completion9 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelofibrosis, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maya Koren-Michowitz, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402399
- Sponsor's protocol ID
- 0124-17
- Acronym
- MRMF01
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No