Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies

Completed · Phase 2

Conditions studied: Hemoglobinopathies, Sickle Cell Disease, Thalassemia

In brief

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 patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored.

Key facts

Study ID

NCT00153985

Run by

Dana-Farber Cancer Institute

People needed

2

Starts

2004-03-01

Expected to finish

2009-07-01

Last updated by the study team

2013-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnancy
• Acute hepatitis
• Cardiac ejection fraction < 30%
• Severe renal impairment
• Severe residual functional neurologic impairment
• Evidence of HIV infection

Where it is running

• Winship Cancer Institute-Emory University — Atlanta, Georgia, United States
• Feist-Weiller Cancer Center-LSU — Shreveport, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Ohio State University College of Medicine — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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