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Study 17 of 211 for search of: | "Hemoglobinopathies" |
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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00578344 |
This is a nonrandomized study looking at organ function improvement after Bone Marrow Transplant (BMT) in Sickle Cell disease(SCD) patients. Specifically, to determine whether organ dysfunction (brain, heart, lung, kidney, liver, spleen, etc.) secondary to these severe hemoglobinopathies can be improved or reversed following allogeneic BMT.
Condition | Intervention |
---|---|
Sickle Cell Disease HEMOGLOBIN SS HEMOGLOBIN SC Hemoglobin Sb0/+ |
Procedure: ALLOGENEIC BMT/SCT Infusion Drug: Busulfan Biological: Campath 1H Drug: Cyclophosphamide and Mesna |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Allogeneic Bone Marrow Transplantation From HLA Identical Related Donors for Patients With Hemoglobinopathies: Hemoglobin SS, Hemoglobin SC, or Hemoglobin SB0/+ Thalassemia |
Estimated Enrollment: | 15 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Patients will receive a BMT as described below:
day -9 Busulfan 4.0 mg/kg/day IV divided into four doses daily for four days; total dose = 16 mg/kg
day -5 through day -2 Campath 1H dosed per institutional guidelines
day -5 through day -2 CTX 50mg/kg +MESNA
day 0 stem cell infusion
Ages Eligible for Study: | up to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with a related HLA genotype identical donor and hemoglobin SS, hemoglobin SC, or hemoglobin Sb0/+ and at least one of the following conditions:
Exclusion Criteria:
4. Patient with severe cardiac dysfunction defined as echocardiogram shortening fraction < 25% or NYHA class III or IV.
5. Patient with HIV infection.
6. Patient with unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate bone marrow transplantation.
7. Patient or patient's guardian(s) unable to understand the nature and risks inherent in the BMT process.
8 Pregnant/lactating women and those unwilling to use acceptable contraception will be excluded.
9. Patient or patient's guardian who have not signed an informed consent.
NOTE: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.
Contact: Kathryn Suet Wa Leung | 832-822-4200 | kleung@bcm.edu |
Contact: Kathryn Suet Wa Leung, MD | 832-822-4200 | kleung@bcm.tmc.edu |
United States, Texas | |
Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Kathryn Suet Wa Leung, MD 832-822-4200 kleung@bcm.tmc.edu | |
Principal Investigator: Kathryn Suet Wa Leung, MD | |
Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: George Carrum, MD 713-441-1450 gcarrum@bcm.edu | |
Contact: Kathryn Suet Wa Leung, MD 832-822-4200 kleung@bcm.tmc.edu | |
Principal Investigator: Kathryn Suet Wa Leung, MD |
Principal Investigator: | Kathryn Suet Wa Leung, MD | Baylor College of Medicine/Texas Children's Hospital |
Responsible Party: | Baylor College of Medicine/Texas Children's Hospital ( Kathryn Suet Wa Leung, MD ) |
Study ID Numbers: | 16447, SCALLOP |
Study First Received: | December 19, 2007 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00578344 |
Health Authority: | United States: Institutional Review Board |
Sickle Cell Disease SCD Hemoglobin SS Hemoglobin SC |
Hemoglobin Sb0/+ HLA genotype Severe anemia Transfusion therapy |
Hemoglobin SC disease Hematologic Diseases Hemoglobin SC Disease Anemia Anemia, Hemolytic Cyclophosphamide Thalassemia Sickle cell anemia |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Busulfan Alemtuzumab Hemoglobinopathies Hemoglobinopathy Mesna Anemia, Sickle Cell |
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 |