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Tissue Banking Study - Polycythemia Vera or Essential Thrombocythemia (PV & ET) Patients

Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01970930
Enrollment
131
Registered
2013-10-28
Start date
2012-08-31
Completion date
2016-06-02
Last updated
2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycythemia Vera, Essential Thrombocythemia

Keywords

Tissue banking

Brief summary

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.

Detailed description

Specific Aim 1: Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function. Specific Aim 2. Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC.

Interventions

4 green top tube 40 cc of blood draw

Sponsors

The Leukemia and Lymphoma Society
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* polycythemia vera or essential thrombocythemia * agree to give blood for study

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Stem cell functionat one time study visitAssess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.

Secondary

MeasureTime frameDescription
CD34+ cells assaysat one time study visitAssess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC. After treatment with RG7112 and IFNα 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026