International Registry for Severe Chronic Neutropenia

Study ID
199/11901

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Leah Adix
214/648-2139
leah.adix@childrens.com

Principal Investigator
George Buchanan, M.D.

Official Title

Brief Overview


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.

Summary


PROTOCOL OUTLINE:

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

Participant Eligibility


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