International Registry for Severe Chronic Neutropenia

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.

Official Title

International Registry for Severe Chronic Neutropenia

Conditions

Neutropenia

Study Type

Observational

Study Design

This study is Natural History based

Further Details

PROTOCOL OUTLINE: Patients are treated by the referring physician as medically indicated. Clinical data are collected at baseline and then every 6 months.

Study Start

June 1994

Eligibility & Criteria

Ages Eligible for Study: 3 Months and above, Genders Eligible for Study: Both 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

Total Enrolment

Total enrolment is expected to be 1000

Contact Details

[1] Central Highlands Oncology Program, Ballarat, Victoria, 3350, Australia; Recruiting George Kannourakis 61-353-334811