Clinical Trial TitleMapping of CD34+ Cells From Healthy Participants and Patients with Myelofibrosis (MF) and Polycythemia Vera (PV)
Clinical Trial Protocol Description:
Myelofibrosis (MF) belongs to a group of closely related blood cancers known as “myeloproliferative neoplasms (MPNs)” in which the bone marrow cells that produce the body’s blood cells develop and function abnormally.
This is a non-treatment study. The purpose of the study is to identify potential new targets for the treatment of myeloproliferative neoplasms. In the study, special blood cells, CD34+ cells, will be collected from patients with MF or PV. These CD34+ cells are special in that they are able to replace themselves and restore all blood cell types. Once collected, the CD34+ cells will be subjected to special testing to look at epigenetic changes. This study will focus on finding the epigenetic changes that are contributing to the abnormal behavior and growth of the blood cells in MF and PV. Similar epigenetic analyses will be performed on CD34+ cells in people without MF or PV. The epigenetic changes unique to MF and PV patients can then be identified. Once identified, these epigenetic changes could be used to identify new treatment approaches for MF and PV.
If you agree to participate in this study, your participation may last up to 28 days and you will be asked to complete one study visit.
Participants with MF will have a peripheral blood draw during which at least 30 milliliters (approximately 6 teaspoons) of blood will be collected in order to collect CD34+ blood cells. If, at a later date, it is determined that a sample contains inadequate viable CD34+ cells, you may be asked to undergo additional peripheral blood draws at which time an additional 30 milliliters of blood will be collected.
Participants with PV will have a usual-care therapeutic phlebotomy of approximately 500 milliliters of blood (approximately 1 quart) in order to collect CD34+ blood cells. If, at a later date, it is determined that a sample contains inadequate viable CD34+ cells, you may be asked to undergo additional usual-care therapeutic phlebotomies in order to collect additional samples of CD34+ blood cells.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older and have a life expectancy of more than 6 months.
- Have a diagnosis of primary myelofibrosis (PMF) or polycythemia vera (PV).
- Have been (newly diagnosed), previously treated, or currently being treated.
- Are willing to undergo peripheral blood draws in order to collect samples for epigenomic testing.
You will be excluded from the study if any of the following criteria apply to you:
- Are participating in any blinded investigational studies or are receiving investigational agents for MF or PV.
- Have a diagnosis of secondary acute myelogenous leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or other myeloid neoplasms.
- Have a history of allogeneic hematopoietic stem cell transplant (HSCT).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.