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

This study is currently recruiting participants.
Verified December 2016 by Icahn School of Medicine at Mount Sinai
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970930
First Posted: October 28, 2013
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  Purpose
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 Intervention
Polycythemia Vera Essential Thrombocythemia Procedure: Blood specimen

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
CD34+ cells isolated from the peripheral blood Splenic CD34+ cells

Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PV or ET
subject who has polycythemia vera or essential thrombocythemia
Procedure: Blood specimen
4 green top tube 40 cc of blood draw

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have polycythemia vera or essential thrombocythemia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970930


Contacts
Contact: Jill Kleczko, MPA 212-241-0573 jill.kleczko@mssm.edu
Contact: Ronald Hoffman, MD 212-241-2296 ronald.hoffman@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Ronald Hoffman, MD         
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
  More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01970930     History of Changes
Other Study ID Numbers: GCO 12-0481
First Submitted: August 20, 2013
First Posted: October 28, 2013
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by Icahn School of Medicine at Mount Sinai:
Tissue banking

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Thrombocytosis
Thrombocythemia, Essential
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders