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Completed

NCT Number: NCT01970930

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

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.

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Key information

Conditions

Polycythemia Vera Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Bone Marrow Neoplasms Essential Thrombocythemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Site Thrombocythemia, Essential Thrombocytosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Blood specimen

Procedure

4 green top tube 40 cc of blood draw

Primary outcomes

  1. Stem cell function

    Time frame: 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 outcomes

  1. CD34+ cells assays

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • The Leukemia and Lymphoma Society

Registry information

Official study title

Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2013
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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