Reversible Secondary Myelofibrosis or Clonal Myeloproliferative Disorder

This study has been withdrawn prior to enrollment.

(This study was stopped due to poor enrollment numbers)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT00722254

First received: July 23, 2008

Last updated: February 17, 2009

Last verified: February 2009

History of Changes

Purpose

To determine the prevalence of myelofibrosis in patients with primary pulmonary hypertension, and to discover if the fibrosis in these patients is primary (AMM) or secondary.

Condition
Primary Myelofibrosis Primary Pulmonary Hypertension Secondary Myelofibrosis Pulmonary Arterial Hypertension

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Reversible Secondary Myelofibrosis or Clonal Myeloproliferative Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: primary myelofibrosis pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Determine the prevalence of myelofibrosis in patients with primary pulmonary hypertension [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Discover if the fibrosis in patients with primary pulmonary hypertension is primary (AMM) or secondary. [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]
Clonality [ Time Frame: After sample is obtained ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole Blood

Estimated Enrollment:	60
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
PPH Subjects diagnosed with primary pulmonary hypertension (PPH)
Myelofibrosis Subjects diagnosed with Primary or Secondary Myelofibrosis

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients suffering from primary pulmonary hypertension or myelofibrosis (primary or secondary)

Criteria

Inclusion Criteria:

> 18 years of age
Signed Informed Consent
Subjects diagnosed with Primary Pulmonary Hypertension or Myelofibrosis (primary or secondary)

Exclusion Criteria:

Anyone not meeting the above inclusion criteria
Pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722254

Locations

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
VA Salt Lake City Health Care System
Salt lake City, Utah, United States, 84148

Sponsors and Collaborators

University of Utah

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Josef T Prchal, MD

University of Utah

More Information

Publications:

Hoffman R, Prchal JT, Samuelson S, Ciurea SO, Rondelli D. Philadelphia chromosome-negative myeloproliferative disorders: biology and treatment. Biol Blood Marrow Transplant. 2007 Jan;13(1 Suppl 1):64-72. Review.

Chen GL, Liu E, Naidoo K, Popat U, Coetzer TL, Prchal JT. Idiopathic myelofibrosis without dacryocytes. Haematologica. 2006 Jun;91(6 Suppl):ECR29.

Popat U, Frost A, Liu E, Guan Y, Durette A, Reddy V, Prchal JT. High levels of circulating CD34 cells, dacrocytes, clonal hematopoiesis, and JAK2 mutation differentiate myelofibrosis with myeloid metaplasia from secondary myelofibrosis associated with pulmonary hypertension. Blood. 2006 May 1;107(9):3486-8. Epub 2006 Jan 17.

Popat U, Frost A, Liu E, May R, Bag R, Reddy V, Prchal JT. New onset of myelofibrosis in association with pulmonary arterial hypertension. Ann Intern Med. 2005 Sep 20;143(6):466-7. No abstract available.

Xu M, Bruno E, Chao J, Huang S, Finazzi G, Fruchtman SM, Popat U, Prchal JT, Barosi G, Hoffman R; MPD Research Consortium. Constitutive mobilization of CD34+ cells into the peripheral blood in idiopathic myelofibrosis may be due to the action of a number of proteases. Blood. 2005 Jun 1;105(11):4508-15. Epub 2005 Feb 10.

Phelan JT 2nd, Prchal JT. Clonality studies in cancer based on X chromosome inactivation phenomenon. Methods Mol Med. 2002;68:251-70. No abstract available.

Damps-Konstańska I, Konstański Z, Jassem E. [Treatment of pulmonary hypertension] Wiad Lek. 2007;60(11-12):545-9. Polish.

Cortelezzi A, Gritti G, Del Papa N, Pasquini MC, Calori R, Gianelli U, Cortiana M, Parati G, Onida F, Sozzi F, Vener C, Bianchi P, Deliliers GL. Pulmonary arterial hypertension in primary myelofibrosis is common and associated with an altered angiogenic status. Leukemia. 2008 Mar;22(3):646-9. Epub 2007 Sep 13. No abstract available.

Halank M, Marx C, Baretton G, Müller KM, Ehninger G, Höffken G. Severe pulmonary hypertension in chronic idiopathic myelofibrosis. Onkologie. 2004 Oct;27(5):472-4.

Responsible Party:	Josef T. Prchal, MD, University of Utah
ClinicalTrials.gov Identifier:	NCT00722254 History of Changes
Other Study ID Numbers:	17806
Study First Received:	July 23, 2008
Last Updated:	February 17, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Myeloproliferative Disorder
Primary Myelofibrosis
Primary Pulmonary Hypertension
Secondary Myelofibrosis
Pulmonary Arterial Hypertension

Flolan
Clonality
CD34+ cells
Hematologic abnormalities

Additional relevant MeSH terms:

Primary Myelofibrosis
Hypertension, Pulmonary
Hypertension
Myeloproliferative Disorders
Bone Marrow Diseases

Hematologic Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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