Polycythemia Vera Clinical Trial
Official title:
Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53
| Verified date | January 2018 |
| Source | Icahn School of Medicine at Mount Sinai |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of the study is to isolate and characterize stem cells of patients with Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not working the way they should be and why they seem to be sensitive to regulatory factors in the blood, such as clotting.
| Status | Completed |
| Enrollment | 131 |
| Est. completion date | June 2, 2016 |
| Est. primary completion date | June 2, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - polycythemia vera or essential thrombocythemia - agree to give blood for study Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Icahn School of Medicine at Mount Sinai | The Leukemia and Lymphoma Society |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Stem cell function | Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function. | at one time study visit | |
| Secondary | CD34+ cells assays | Assess the effects of a combination of low doses of IFNa and RG7112 on MPN HSC/HPC. After treatment with RG7112 and IFNa at the various doses, p53, MDM2, MDMX, phosphor-p38, and phosphor-STAT1 levels in MPN CD34+ cells will be measured using monoclonal antibody staining and flow cytometric and immunofluorescence analyses. | at one time study visit |
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