International Registry for Severe Chronic Neutropenia
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | June 1994 |
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.
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.
PROTOCOL OUTLINE:
Patients are treated by the referring physician as medically indicated. Clinical data are
collected at baseline and then every 6 months.
Patients are treated by the referring physician as medically indicated. Clinical data are
collected at baseline and then every 6 months.
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
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