Reversible Secondary Myelofibrosis or Clonal Myeloproliferative Disorder

NCT00722254 | Terminated

• 2 other identifiers: 178061P01CA108671-01A2
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Primary Myelofibrosis; Primary Pulmonary Hypertension; Secondary Myelofibrosis; Pulmonary Arterial Hypertension

Keywords

Myeloproliferative Disorder; Primary Myelofibrosis; Primary Pulmonary Hypertension; Secondary Myelofibrosis; Pulmonary Arterial Hypertension; Flolan; Clonality; CD34+ cells; Hematologic abnormalities

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of myelofibrosis in patients with primary pulmonary hypertension

  After sample is obtained

Secondary Outcomes (2)

• Discover if the fibrosis in patients with primary pulmonary hypertension is primary (AMM) or secondary.

  After sample is obtained

• Clonality

  After sample is obtained

Study Arms (2)

PPH

Subjects diagnosed with primary pulmonary hypertension (PPH)

Myelofibrosis

Subjects diagnosed with Primary or Secondary Myelofibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

VA Salt Lake City Health Care System

Salt Lake City, Utah, 84148, United States

Location

Related Publications (9)

• 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. doi: 10.1016/j.bbmt.2006.11.003.

  PMID: 17222772 BACKGROUND

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

  PMID: 16785132 BACKGROUND

• 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. doi: 10.1182/blood-2005-08-3319. Epub 2006 Jan 17.

  PMID: 16418333 BACKGROUND

• 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. doi: 10.7326/0003-4819-143-6-200509200-00017. No abstract available.

  PMID: 16172450 BACKGROUND

• 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. doi: 10.1182/blood-2004-08-3238. Epub 2005 Feb 10.

  PMID: 15705794 BACKGROUND

• Phelan JT 2nd, Prchal JT. Clonality studies in cancer based on X chromosome inactivation phenomenon. Methods Mol Med. 2002;68:251-70. doi: 10.1385/1-59259-135-3:251. No abstract available.

  PMID: 11901507 BACKGROUND

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

  PMID: 18540180 BACKGROUND

• 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. doi: 10.1038/sj.leu.2404943. Epub 2007 Sep 13. No abstract available.

  PMID: 17851555 BACKGROUND

• Halank M, Marx C, Baretton G, Muller KM, Ehninger G, Hoffken G. Severe pulmonary hypertension in chronic idiopathic myelofibrosis. Onkologie. 2004 Oct;27(5):472-4. doi: 10.1159/000080368.

  PMID: 15585978 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Primary Myelofibrosis; Familial Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Josef T Prchal, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: June 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 21, 2016

Record last verified: 2016-03

Locations

US (2)