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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT01970930

Collaborator

The Leukemia and Lymphoma Society (Other)

131

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera Essential Thrombocythemia	Procedure: Blood specimen

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 Design

Study Type:

Observational

Actual Enrollment :

131 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jun 2, 2016

Actual Study Completion Date :

Jun 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
PV or ET subject who has polycythemia vera or essential thrombocythemia	Procedure: Blood specimen 4 green top tube 40 cc of blood draw

Arm

Intervention/Treatment

PV or ET

subject who has polycythemia vera or essential thrombocythemia

Procedure: Blood specimen

4 green top tube 40 cc of blood draw

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

polycythemia vera or essential thrombocythemia
agree to give blood for study

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

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

Investigators

Principal Investigator: Ronald Hoffman, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT01970930

Other Study ID Numbers:

GCO 12-0481

First Posted:

Oct 28, 2013

Last Update Posted:

Jan 19, 2018

Last Verified:

Jan 1, 2018

Keywords provided by Icahn School of Medicine at Mount Sinai

Tissue banking

Additional relevant MeSH terms:

Polycythemia Vera

Polycythemia

Thrombocytosis

Thrombocythemia, Essential

Study Results

No Results Posted as of Jan 19, 2018