International Registry for Severe Chronic Neutropenia - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

June 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004342 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

International Registry for Severe Chronic Neutropenia

Official Title ^ICMJE

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History

Condition ^ICMJE

Neutropenia

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Months and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Australia, Canada, Germany, Italy, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00004342

Responsible Party

Study ID Numbers ^ICMJE

199/11901, UW-730

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

University of Washington

Investigators ^ICMJE

Study Chair:

David Chandler Dale

University of Washington

Information Provided By

National Center for Research Resources (NCRR)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP