Severe Chronic Neutropenia International Registry Protocol

K
Kathleen Overholt, MD

Primary Investigator

Overview

The objective of the registry is to collect information on the natural course of severe chronic neutropenia (SCN) and its response to treatment with the blood-stimulating factor called granulocyte colony stimulating factor or G-CSF (Neupogen).

Description

The objective of the registry is to collect information on the natural course of severe chronic neutropenia (SCN) and its response to treatment with the blood-stimulating factor called granulocyte colony stimulating factor or G-CSF (Neupogen).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Neutropenia
  • Age: - 100 Years
  • Gender: All

Inclusion Criteria
A confirmed diagnosis of severe chronic neutropenia based on documented absolute neutrophil counts in the three months prior to enrollment.
Bone marrow aspiration consistent with the diagnosis of congenital, cyclic or idiopathic neutropenia.
Normal cytogenetic evaluation.
History of recurrent infections (i.e. severe mouth ulcers, gingivitis and sinusitis).
Age greater than three months.
Independent of hematological parameters, patients with the following diagnoses may be included: Shwachman-Diamond syndrome (SDS), glycogen storage disease type Ib (GSD1b), Barth syndrome.
Patients with moderately severe chronic neutropenia and recurrent severe infections (i.e., deep tissue infections of subcutaneous areas, lungs, liver, etc.).
Immune neutropenia with positive anti-neutrophil antibodies meeting criteria in 1, 3, 5 and 6.
All SCN patients previously enrolled in Amgen-sponsored SCN studies.
Exclusion Criteria
Neutropenia known to be drug induced.
Primary myelodysplasia
Primary leukemia
Aplastic anemia
Known HIV disease
Systemic autoimmune diseases such as rheumatoid arthritis or systemic lupus, erythematosus
Chemotherapy-induced neutropenia (within the last 5 years)
Additional Information:
Participants will not be paid for their participation.

Updated on 07 Jul 2023. Study ID: 1011004393

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center