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

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ClinicalTrials.gov Identifier: NCT01970930
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 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 : August 2012
Actual Primary Completion Date : June 2, 2016
Actual Study Completion Date : June 2, 2016


Group/Cohort 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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


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


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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:


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


Locations
United States, New York
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

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01970930     History of Changes
Other Study ID Numbers: GCO 12-0481
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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

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