Thrombocytopenia Clinical Trial
Verified date | December 2001 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating
factor (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin
level in patients with inherited bone marrow failure syndromes.
II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily
G-CSF.
III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor
colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before
and after G-CSF using flow cytometry and immunohistochemistry.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Inherited bone marrow failure syndrome, including: - Fanconi's anemia - Dyskeratosis congenita - Shwachman syndrome - Amegakaryocytic thrombocytopenia - Decreased megakaryocytes in infancy - No thrombocytopenia with absent radius syndrome (TAR) - No trisomy 13 or 18 - No clonal bone marrow karyotype --Prior/Concurrent Therapy-- - At least 4 weeks since growth factors - Concurrent therapy allowed if not altered for 30 days prior to entry through week 8 - No concurrent investigational drugs --Patient Characteristics-- - Hematopoietic: ANC <1000 - No leukemia - Other: No medical or psychiatric contraindication to protocol participation - No pregnant or nursing women |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Center for Research Resources (NCRR) | James Whitcomb Riley Hospital for Children |
Rackoff WR, Orazi A, Robinson CA, Cooper RJ, Alter BP, Freedman MH, Harris RE, Williams DA. Prolonged administration of granulocyte colony-stimulating factor (filgrastim) to patients with Fanconi anemia: a pilot study. Blood. 1996 Sep 1;88(5):1588-93. — View Citation
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