Status:
COMPLETED
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Hemoglobinopathies
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patie...
Detailed Description
* In order to undergo transplant procedure, patients will be admitted to the hospital for approximately 10-14 days. * To prepare patient's bone marrow to accept donor stem cells, they will receive flu...
Eligibility Criteria
Inclusion
- Patients with sickle cell disease should have one or more of the following: acute chest syndrome requiring hospitalization; nonhemorrhagic stroke or central nervous system event lasting longer than 24 hours; recurrent caso-occlusive pain or recurrent priapism; sickle neuropathy; bilateral proliferative retinopathy and major visual impairment of at least one eye; osteonecrosis of multiple joints; transfusion dependence; vaso-occlusive.
- Patients with thalassemia should have one or more of the following: transfusion dependence; iron overload; presence of 2 or more alloantibodies against red cell antigens.
Exclusion
- Pregnancy
- Acute hepatitis
- Cardiac ejection fraction \< 30%
- Severe renal impairment
- Severe residual functional neurologic impairment
- Evidence of HIV infection
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00153985
Start Date
March 1 2004
End Date
July 1 2009
Last Update
July 30 2013
Active Locations (6)
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1
Winship Cancer Institute-Emory University
Atlanta, Georgia, United States, 30322
2
Feist-Weiller Cancer Center-LSU
Shreveport, Louisiana, United States, 71130
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115