Status:
COMPLETED
Assess the Feasibility and Safety of Granulocyte Colony Stimulating Factor (GCSF) Mobilization of CD34+ Hematopoietic Progenitor Cells in Patients With Betathalassemia Major
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Beta Thalassemia Major
Congenital Anemias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Betathalassemia major is a disease of the blood and bone marrow. You were born with it and it has made you unable to make normal hemoglobin and red cells. You have been receiving red blood cell transf...
Eligibility Criteria
Inclusion
- Subjects must be 18 years or older
- Subjects may be of either gender or of any ethnic background
- Subjects must have a confirmed diagnosis of ßthalassemia major and have been enrolled in a hypertransfusion program with a confirmed annual transfusion of ≥ or = to 100 mL/kg/yr AND ≥ or = to 8 Transfusions of blood per year over a minimum of two years.
- Patients must be off hydroxyurea (HU) or erythropoietin (EPO) treatment for at least three months prior to entry onto the study
- Subjects must have a performance score of Karnofsky \> or = to 70 of the time of entry into the study.
- Subjects must have a normal EKG and a normal chest xray
- Each patient must be willing to participate as a research subject and must sign an informed consent form.
- Subjects must be splenectomized or have no palpable spleen
- Negative pregnancy test, if female
Exclusion
- Active infections including Hepatitis B and C, HTLV 1 and 2, West Nile Virus, and HIV 1
- Female patient pregnant or breast feeding
- Patients with uncontrolled seizure disorders
- Allergy to GCSF or bacterial E. coli products
- History of sickle cell disease or sickle trait
- History of thrombosis or known thrombophilia
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00658385
Start Date
April 1 2008
End Date
February 1 2011
Last Update
November 25 2016
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065