Status:
COMPLETED
Evaluating the Safety of G-CSF Mobilization in Individuals With Beta Thalassemia Major
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
George Papanicolaou Hospital
Conditions:
Beta-Thalassemia
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Beta thalassemia major is a serious genetic disease of the blood. Treatments are limited, and although a bone marrow transplant from a compatible donor can be curative, only a limited percentage of in...
Detailed Description
Primary Objective: To determine the safety of PBSC mobilization with G-CSF, with or without HU pretreatment in adults with beta thalassemia major. Secondary Objective: To determine the number of CD34...
Eligibility Criteria
Inclusion
- β-thalassemia major
- Karnofsky performance status greater than or equal to 80%
- Splenectomized patients or patients with spleen volume less than 800 cm\^3 (V=0.523 x length x thickness x width)
- Compliant with regular transfusions and regular chelation
- Liver iron by magnetic resonance imaging (MRI) less than 280 μmol/gr or greater than or equal to 1.7 msec by T2\*MRI
- Heart iron by MRI greater than 2.8 (SI/SD)or greater than or equal to 9 msec by T2\*MRI
- Hepatitis B or C virus load negative by polymerase chain reaction (PCR)
- Left ventricular ejection fraction (LVEF) greater than 45% by echocardiogram or multiple gated acquisition scan (MUGA)
- Adequate respiratory function with diffusing capacity of the lung for carbon monoxide (DLCO) greater than 50%
- Negative pregnancy test, if female
- Ability to give informed consent and willingness to meet all the expected requirements of the protocol for the duration of the study
Exclusion
- History of thrombosis or known thrombophilia
- Symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility evaluation
- Pregnant or breastfeeding
- HIV positivity
- History of cancer, other than local skin cancer
- Other systematic disease
- Splenectomized patients with platelet count greater than 900,000
- Additional risk factors for thrombosis, including Factor V Leiden; antiphospholipid antibodies; and less than 50% of the lowest normal value for the following procoagulants: antithrombin 3, protein C, or protein S
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00336362
Start Date
July 1 2006
End Date
August 1 2010
Last Update
December 20 2012
Active Locations (1)
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1
George Papanicolaou Hospital
Thessaloniki, Greece