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

Completed

• Conditions: Polycythemia Vera; Essential Thrombocythemia
• Interventions: Procedure: Blood specimen

• Registration Number: NCT01970930
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Primary Completion: 2016-06-02
• Study Completion: 2016-06-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PV or ET	Blood specimen	subject who has polycythemia vera or essential thrombocythemia

Primary Outcome Measures

Name	Time	Method
Stem cell function	at one time study visit	Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.

Secondary Outcome Measures

Name	Time	Method
CD34+ cells assays	at one time study visit	Assess 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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States