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
- Are there results?
- None posted in the registry
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
Tsrifin
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
- ClinicalTrials.gov ID
- NCT03402399
- Acronym / sponsor ID
- MRMF01 / 0124-17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 9 Dec 2019 (estimated)
- Study completion
- 9 Dec 2020 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Myelofibrosis | Other | Other: Molecular analysisBlood test |
| Secondary Myelofibrosis | Other | Other: Molecular analysisBlood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling or unable to provide informed consent
- Prefibrotic MF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular analysisBlood test | Other | Primary Myelofibrosis, Secondary Myelofibrosis |
Primary outcome
Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF
Time frame: Baseline
Proportions of patients with HMR mutations in each arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Koren-Michowitz, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirly Broitman (+972-8-9778452, shirlib@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.