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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00186797 |
This study is for patients with Severe Aplastic Anemia (SAA). A stem cell transplant from a genetically matched sibling donor can help or cure this disease in 85 to 100 percent of patients. Stem cells are immature blood cells that grow to become red blood cells, white blood cells or platelets. A genetic "match" means a brother or sister has same immune type (HLA type) as the patient. Unfortunately, few patients have a matched sibling donor. The chance of negative outcomes is much higher with other types of donors.
This study will test the success of a new approach to stem cell transplant for SAA. Patients in this study will receive drugs and radiation treatment to destroy their diseased bone marrow and to prepare them for stem cell transplant. Bone marrow is the tissue inside the bones where stem cells are made.Stem cells will be harvested from the blood or bone marrow of genetically matched unrelated donors or partially matched family donors. The stem cells will be filtered using a new device that is currently under study. The patients will receive large doses of the filtered stem cells (stem cell graft). Researchers want to find out how the study treatment affects patients, the disease, and the chances for survival.
Condition | Intervention |
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Aplastic Anemia |
Procedure: Allogeneic stem cell transplant Drug: Fludarabine, Cyclophosphamide |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Estimated Enrollment: | 28 |
Study Start Date: | December 2002 |
Study Completion Date: | May 2007 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 |
Principal Investigator: | Paul Woodard, MD | St. Jude Children's Research Hospital |
Study ID Numbers: | AACD34 |
Study First Received: | September 9, 2005 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00186797 |
Health Authority: | United States: Food and Drug Administration |
Aplastic Anemia |
Hematologic Diseases Anemia, Aplastic Anemia Fludarabine |
Fludarabine monophosphate Cyclophosphamide Aplastic anemia Bone Marrow Diseases |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Myeloablative Agonists |
Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Pharmacologic Actions |