|
Bone Marrow Transplantation in Treating Children With Sickle Cell Disease Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Bone Marrow Transplantation in Treating Children With Sickle Cell Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Bone Marrow Transplantation in Treating Children With Sickle Cell Disease Clinical research trials and Bone Marrow Transplantation in Treating Children With Sickle Cell Disease medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Bone Marrow Transplantation in Treating Children With Sickle Cell Disease. Bone Marrow Transplantation in Treating Children With Sickle Cell Disease Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Bone Marrow Transplantation in Treating Children With Sickle Cell Disease clinical trial. Subjects typically recieve the finest healthcare available for their Bone Marrow Transplantation in Treating Children With Sickle Cell Disease condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bone Marrow Transplantation in Treating Children With Sickle Cell Disease  Bone Marrow Transplantation in Treating Children With Sickle Cell Disease
Bone Marrow Transplantation in Treating Children With Sickle Cell Disease
For Condition: Sickle Cell Anemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center ,
Synopsis: RATIONALE: Sickle cell disease is an inherited disorder in which abnormal, crescent-shaped red blood cells interfere with the ability of the blood to carry oxygen through the body and can cause severe pain, stroke, and organ damage. Bone marrow transplantation, is a procedure in which the soft, sponge-like tissue in the center of bones producing white blood cells, red blood cells, and platelets is replaced by bone marrow from a another person. Bone marrow transplantation may be an effective treatment in relieving the symptoms of sickle cell disease. PURPOSE: Phase I/II trial to study the effectiveness of bone marrow transplantation in treating children who have sickle cell disease.
Details: PROTOCOL OUTLINE: This is a multicenter study. Patients undergo total body irradiation on day 0, followed by allogeneic bone marrow transfusion. Patients also receive fludarabine IV daily and cyclosporine IV twice a day on days -1 to 1. Patients then receive oral cyclosporine on days 1-90, and oral mycophenolate mofetil twice a day on days 0-27. Patients are followed for 100 days, monthly for 6 months and then annually for 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /16 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of sickle cell anemia with clinically severe disease manifestations defined by: Recurrent painful events (at least 2 painful events in past year) which cannot be explained by other causes Pain lasts at least 4 hours Requires treatment with parenteral narcotics, equianalgesic dose of oral narcotics, or parenteral nonsteroidal antiinflammatory drugs Acute chest syndrome (ACS) with at least 2 episodes within past 2 years that required hospitalization, oxygen, and RBC transfusion Any combination of painful events and ACS episodes that total 2 events within the past year Abnormal cerebral MRI, abnormal angiography (MR or conventional), and abnormal neuropsychologic testing performance No stage III or IV sickle cell lung disease Genotypically HLA identical sibling donor available --Prior/Concurrent Therapy-- No prior transfusions with greater than 5 units RBC --Patient Characteristics-- Performance status: Karnofsky 70-100% Hepatic: - No active hepatitis - No moderate/severe portal fibrosis Renal: Glomerular filtration rate at least 30% predicted for age Neurologic: - No severe residual functional neurologic impairment - Hemiplegia alone allowed Other: - HIV negative - Not pregnant or nursing - Fertile patients must use effective contraception
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
MarkWalters, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Ann Woolfrey 206-667-4453
Children's Hospital of Oakland *Recruiting*
Oakland, California, 94609
United States
Recruiting Mark Walters 510-428-3374
Additional Information:
Study ID Numbers: 199/14243; FHCRC-1373.00
Study Start Date: December 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004485
Other Sickle Cell Anemia Studies:
1. Nitric Oxide to Improve Blood Flow in Sickle Cell Disease
2. Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
3. Pilot Study of Fructose for Sickle Cell Crisis
4. Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes
5. Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy
Related Studies:
Other Sickle Cell Anemia Clinical Trials
Other California Clinical Trials
Other Oakland Clinical Trials
Bone Marrow Transplantation in Treating Children With Sickle Cell Disease
|
|
|
|
|
|
|
|
