International Registry for Severe Chronic Neutropenia

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), December 2003

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Washington
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004342

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
Neutropenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	1000
Study Start Date:	June 1994

Detailed Description:

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 older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Severe chronic neutropenia (SCN), i.e.: Absolute neutrophil count less than 500/mm3 on 3 occasions within the last 3 months (less than 200/mm3 for cyclic neutropenia) Bone marrow aspirate consistent with SCN History of infection No drug induced neutropenia No myelodysplastic syndrome No aplastic anemia No thrombocytopenia or anemia unless due to Shwachman-Diamond syndrome or glycogen storage disease type IB Prior enrollment on Amgen SCN trials eligible Bone marrow aspiration within 1 year required Cytogenetic evaluation strongly suggested --Prior/Concurrent Therapy-- At least 5 years since prior chemotherapy --Patient Characteristics-- No rheumatoid arthritis No systemic lupus erythematosus No HIV seropositivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004342

Locations

United States, Michigan
Women's Hospital	Recruiting
Ann Arbor, Michigan, United States, 48109-0266
Contact: Laurence A. Boxer 734-764-7127
United States, New Jersey
St. Barnabas Medical Center	Recruiting
Livingston, New Jersey, United States, 07039
Contact: Donna Mura 973-322-8076 dmura@sbhcs.com
United States, Washington
University of Washington School of Medicine	Recruiting
Seattle, Washington, United States, 98195
Contact: David Chandler Dale 206-543-7215
Australia, Victoria
Central Highlands Oncology Program	Recruiting
Ballarat, Victoria, Australia, 3350
Contact: George Kannourakis 61-353-334811
Canada, Manitoba
CancerCare Manitoba	Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Bonnie Paula Cham 204-787-4147
Canada, Ontario
Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Melvin H. Freedman 416-813-6152
Germany
Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, D-30625
Contact: Karl Welte 0511-532-6710
Italy
Istituto Giannina Gaslini	Recruiting
Genova, Italy, 16148
Contact: Pier G. Mori 10-5636-331
United Kingdom, England
St. James's Hospital	Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Sally Kinsey 113 243 31 44

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Washington

Investigators

Study Chair:

David Chandler Dale

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.

Study ID Numbers:	199/11901, UW-730
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004342 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

chronic neutropenia
disease-related problem/condition
hematologic disorders

neutropenia
rare disease
severe chronic neutropenia

Study placed in the following topic categories:

Neutropenia
Hematologic Diseases
Chronic Neutropenia
Agranulocytosis

Rare Diseases
Leukocyte Disorders
Leukopenia
Granulocytopenia

Additional relevant MeSH terms:

Neutropenia
Hematologic Diseases
Agranulocytosis
Leukocyte Disorders
Leukopenia

ClinicalTrials.gov processed this record on May 07, 2009