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Clinical Trial: International Registry for Severe Chronic Neutropenia
This study is currently recruiting patients.
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Purpose
OBJECTIVES: I. Document the clinical course of severe chronic neutropenia (SCN). II. Monitor and assess long term safety of primary treatment in SCN patients in the United States, Canada, Europe, and Australia. III. Study the incidence and outcome of adverse events such as osteoporosis, splenomegaly, cytogenetic abnormalities, myelodysplastic syndrome, and leukemia. IV. Evaluate growth and development and hematologic parameters. V. Monitor for clinically significant changes in primary treatment response over time. VI. Establish a physician network to increase the understanding of SCN. VII. Establish a demographic database to allow for future research.
| Condition |
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| Neutropenia |
MedlinePlus related topics: Blood and Blood Disorders
Study Type: Observational
Study Design: Natural History
Expected Total Enrollment: 1000
Study start: June 1994
PROTOCOL OUTLINE: Patients are treated by the referring physician as medically indicated. Clinical data are collected at baseline and then every 6 months.
Eligibility
Ages Eligible for Study: 3 Months and above, Genders Eligible for Study: Both
Criteria
Location and Contact Information
Michigan
Women's Hospital, Ann Arbor, Michigan, 48109-0266, United States; Recruiting
New Jersey
St. Barnabas Medical Center, Livingston, New Jersey, 07039, United States; Recruiting
Washington
University of Washington School of Medicine, Seattle, Washington, 98195, United States; Recruiting
Australia, Victoria
Central Highlands Oncology Program, Ballarat, Victoria, 3350, Australia; Recruiting
Canada, Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada; Recruiting
Canada, Ontario
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Recruiting
Germany
Medizinische Hochschule Hannover, Hannover, D-30625, Germany; Recruiting
Italy
Istituto Giannina Gaslini, Genova, 16148, Italy; Recruiting
United Kingdom, England
St. James's Hospital, Leeds, England, LS9 7TF, United Kingdom; Recruiting
David Chandler Dale, Study Chair, University of Washington
More Information
Publications
Dale DC, Bonilla MA, Boxer L, et al.: Development of AML/MDS in a subset of patients (PTS) with severe chronic neutropenia (SCN). Blood 84(10 suppl 1): 518a, 1994.
Guerra J, Withers DA, Boxer LM. Myb binding sites mediate negative regulation of c-myb expression in T-cell lines. Blood. 1995 Sep 1;86(5):1873-80.
Welte K, Dale D. Pathophysiology and treatment of severe chronic neutropenia. Ann Hematol. 1996 Apr;72(4):158-65. Review.
Kalra R, Dale D, Freedman M, Bonilla MA, Weinblatt M, Ganser A, Bowman P, Abish S, Priest J, Oseas RS, et al. Monosomy 7 and activating RAS mutations accompany malignant transformation in patients with congenital neutropenia. Blood. 1995 Dec 15;86(12):4579-86.
Record last reviewed: December 2003
Last Updated: March 25, 2005
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004342
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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