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Home > "P" Clinical Trials Conditions > Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy  Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy
Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy
For Condition: Graft Versus Host Disease,Sickle Cell Anemia,Thalassemia
Status: Recruiting
Sponsor(s): Fairview University Medical Center ,
Synopsis: OBJECTIVES: I. Demonstrate the absence of grade 3 or 4 regimen related toxicity in patients with high risk hemoglobinopathy treated with busulfan, fludarabine, anti-thymocyte globulin, and radiotherapy followed by allogeneic hematopoietic stem cell transplantation. II. Determine the incidence of chimerism at 100 days, 6 months, and 1 year following this treatment regimen in this patient population. III. Determine the incidence of grade 2-4 and 3-4 acute graft vs host disease (GVHD) at 100 days following this treatment regimen in this patient population. IV. Determine the incidence of chronic GVHD at 6 months and 1 year following this treatment regimen in this patient population. V. Compare the quality of life at 1 year with the pretransplant assessment in these patients treated with this regimen. VI. Determine the survival at 100 days and 1 year in these patients.
Details: PROTOCOL OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 12 hours on Days -8 and -7, fludarabine IV over 30 minutes daily on Days -6 through -2, anti-thymocyte globulin IV over 8 hours on Days -5 through -1, and total lymphoid radiotherapy on Day -1. Patients undergo allogeneic bone marrow transplantation or umbilical cord blood transplantation on Day 0. Patients receive immunosuppressive therapy consisting of cyclosporine IV over 2 hours every 8 hours and then orally beginning on Day -3 and continuing for at least 6 months and mycophenolate mofetil IV or orally twice daily beginning on Day 0 and continuing until Day 45. Quality of life is assessed daily on Days -10 through 0. Patients are followed at 6, 9, 12, and 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /35 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of sickle cell disease with at least one of the following: stroke, CNS hemorrhage, or neurologic event lasting more than 24 hours or abnormal cerebral MRI or cerebral arteriogram or MRI angiographic study and impaired neuropsychological testing; acute chest syndrome with a history of recurrent hospitalizations or exchange transfusions; recurrent vasoocclusive pain of at least 3 episodes a year for at least 3 years or recurrent priapism; impaired neuropsychological function and abnormal cerebral MRI scan; stage I or II sickle lung disease; sickle nephropathy; moderate or severe proteinuria or glomerular filtration rate 30-50% predicted; bilateral proliferative retinopathy and major visual impairment in at least 1 eye; osteonecrosis of multiple joints with documented destructive changes; require chronic transfusions but with RBC alloimmunization of more than 2 antibodies during long term transfusion therapy OR Transfusion dependent thalassemia Donor requirements: HLA identical OR one HLA antigen mismatched bone marrow OR no more than 2 HLA antigen mismatched umbilical cord blood --Prior/Concurrent Therapy-- No prior radiotherapy that would preclude total lymphoid irradiation --Patient Characteristics-- Performance status: Karnofsky 70-100% OR Lansky 70-100% Hepatic: No acute hepatitis OR no evidence of moderate or severe portal fibrosis or cirrhosis on biopsy Renal: GFR at least 30% predicted Pulmonary: no stage III or IV lung disease Other: No active, serious infection requiring IV antibiotics 1 week prior to study; HIV negative; No AIDS related complex or AIDS; no invasive Aspergillus infection within the past year; no psychological condition or documented medical noncompliance that would preclude study; not pregnant or nursing
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
LakshmananKrishnamurti, Study Chair, Fairview University Medical Center
Fairview University Medical Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Lakshmanan Krishnamurti 612-626-2778
Additional Information:
Study ID Numbers: 199/15108; UMN-MT-9823,UMN-MT-1998-23
Study Start Date: March 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005897
Other Thalassemia Studies:
1. Combination Iron Chelation Therapy
2. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
3. Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy
4. Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
5. Deferoxamine for the Treatment of Hemochromatosis
Related Studies:
Other Thalassemia Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Phase I/II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation in Patients With High Risk Hemoglobinopathy
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