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Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies Clinical research trials and Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies clinical trial. Participants oftentimes recieve the most expert healthcare available for their Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies  Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
For Condition: Thalassemia,Hemoglobinopathy,Sickle Cell Anemia
Status: Terminated
Sponsor(s): Baylor College of Medicine , Texas Children's Hospital,The Methodist Hospital
Synopsis: The major goal of this study is to determine the risks and benefits of stem cell transplants in combination with a newer, less toxic conditioning chemotherapy treatment in patients with severe sickle cell disease (SCD) or sickle hemoglobin variants (hemoglobin SC or hemoglobin SB0/+), or homozygous b0/+ thalassemia or severe B0/+ thalassemia variants. Participation in this project will be for one year, with follow up evaluations done every 6 months thereafter for 10 years or until participants are 18 years old.
Details: To do the stem cell transplant, we must first kill most of the cells in the bone marrow that make the sickle hemoglobin or abnormal blood cells of severe beta thalassemia. We will do this by using a single dose of body irradiation and two drugs called Fludarabine and Campath-IH. The treatment schedule is as follows: Day - 6: Total body irradiation Day - 5: Fludarabine and Campath 1H Day - 4: Fludarabine and Campath 1H Day - 3: Fludarabine and Campath 1H Day - 2: Fludarabine and Campath 1H Day - 1: REST Day 0: Stem Cell Transplant (infusion) After the drug treatment, participants will be given healthy stem cells from a related donor that partially matches their HLA (immune) type, most likely from a parent or sibling. This is known as the stem cell transplant. The healthy stem cells will be put into a blood vein in the same way that transfusions are given. The cells then travel to the right places in the body, where they should grow and make new blood cells that do not sickle.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: Inclusion: - Patients with a haploidentical related HLA donor and hemoglobin SS, hemoglobin SC, or hemoglobin Sb0/+ thalassemia and at least one of the following conditions: 1) previous central nervous system vaso-occlusive episode with or without residual neurologic findings; 2) frequent painful vaso-occlusive episodes which significantly interfere with normal life activities and which necessitate chronic transfusion therapy; 3) recurrent SCD chest syndrome events, which necessitate chronic transfusion therapy; 4) severe anemia, which prevents acceptable quality of life and necessitates chronic transfusion therapy. - Patients with a haploidentical related HLA donor and homozygous b0/+ thalassemia or severe variants of b0/+ thalassemia and require chronic transfusion therapy. - Women of childbearing potential must have a negative pregnancy test. - Between the ages of birth and 65 years. Exclusion: - HLA identical or 5/6 HLA matched sibling donor - Biopsy proven chronic active hepatitis or portal fibrosis. - SCD chronic lung disease > stage 3 Severe renal dysfunction defined as creatinine clearance <40 ml/min/1.73 M2. - Severe cardiac dysfunction defined as shortening fraction <25%. - HIV infection. - Unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate Stem Cell Transplant. - Patient or guardian(s) unable to understand the nature and risks inherent in the stem cell transplant process. - Pregnant or lactating females and those unwilling to use acceptable contraception.
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
MalcolmBrenner, Principal Investigator, Baylor College of Medicine
The Methodist Hospital
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: H8750; Smallo
Study Start Date: August 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040417
Other Hemoglobinopathy Studies:
1. Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
2. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
3. Stem Cell Transplantation after Reduced-Dose Chemotherapy for Patients with Sickle Cell Disease or Thalassemia
4. Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)
5. Combination Iron Chelation Therapy
Related Studies:
Other Hemoglobinopathy Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
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