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Study 1 of 211 for search of: | "Hemoglobinopathies" |
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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Massachusetts General Hospital Brigham and Women's Hospital Emory University Feist-Weiller Cancer Center at Louisiana State University Health Sciences Ohio State University |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00153985 |
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.
Condition | Intervention | Phase |
---|---|---|
Hemoglobinopathies Sickle Cell Disease Thalassemia |
Drug: Busulfex Drug: Fludarabine Drug: Alemtuzumab Procedure: Stem Cell Transfusion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multi-Center Study Using Allogeneic Stem Cell Transplantation Following Reduced Intensity Chemotherapy in Patients With Hemoglobinopathies |
Estimated Enrollment: | 20 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine J. Wu, MD | 617-632-5943 | catherine_wu@dfci.harvard.edu |
United States, Georgia | |
Winship Cancer Institute-Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Louisiana | |
Feist-Weiller Cancer Center-LSU | Recruiting |
Shreveport, Louisiana, United States, 71130 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
United States, Ohio | |
Ohio State University College of Medicine | Recruiting |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Catherine J. Wu, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Catherine J. Wu, MD ) |
Study ID Numbers: | 03-338 |
Study First Received: | September 8, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00153985 |
Health Authority: | United States: Institutional Review Board |
Hemoglobinopathies Sickle cell anemia sickle cell-hemoglobin C disease sickle cell-B-thalassemia transfusion-dependant thalassemia |
allogeneic transplant nonmyeloablative transplant Stem cell transfusion graft vs. host disease |
Hemoglobin SC disease Hematologic Diseases Graft versus host disease Hemoglobin SC Disease Beta-thalassemia Anemia Anemia, Hemolytic Fludarabine monophosphate Thalassemia Sickle cell anemia Homologous wasting disease |
Anemia, Hemolytic, Congenital Thalassemia minor Genetic Diseases, Inborn Busulfan Alemtuzumab Beta-Thalassemia Hemoglobinopathies Graft vs Host Disease Fludarabine Hemoglobinopathy Anemia, Sickle Cell |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents Immunosuppressive Agents Pharmacologic Actions |