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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03402399 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Assaf-Harofeh Medical Center |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Maya Koren-Michowitz, MD |
Principal Investigator Affiliation | Assaf-Harofeh Medical Center |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Israel |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Myelofibrosis, Primary, Myelofibrosis, Post PV, Myelofibrosis, Post ET |
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.
Other: Primary Myelofibrosis
Blood test
Other: Secondary Myelofibrosis
Blood test
Other: - Molecular analysis
Blood test
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Assaf Harofeh Medical Center
Zerifin, ,