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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01970930
First received: August 20, 2013
Last updated: June 6, 2014
Last verified: June 2014
  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 Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Stem cell function [ Time Frame: at one time study visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: August 2015
Estimated Primary Completion Date: August 2015 (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

Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Mount Sinai School of Medicine
The Leukemia and Lymphoma Society
Investigators
Principal Investigator: Ronald Hoffman, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01970930     History of Changes
Other Study ID Numbers: GCO 12-0481
Study First Received: August 20, 2013
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Tissue banking

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

ClinicalTrials.gov processed this record on October 23, 2014