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Cyclophosphamide and Antithymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing a Donor Bone Marrow Transplant - NCT00343785-84132(Clinical Trial 146127)



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City:  Salt Lake City
State:  
UT
Zip Code: 84132
Conditions: Graft Versus Host Disease - Nonmalignant Neoplasm
Purpose: RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's bone marrow. The donated bone marrow stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a smaller than usual dose of bone marrow stem cells and giving antithymocyte globulin, cyclosporine and methotrexate before or after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with antithymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-versus-host disease in patients with severe aplastic anemia undergoing a reduced-dose donor bone marrow transplant.
Study summary: OBJECTIVES: Primary - Minimize the incidence of chronic graft-versus-host disease (GVHD) by restricting the transplanted marrow dose in patients with severe aplastic anemia undergoing HLA-matched related bone marrow transplantation. - Develop a better understanding of which cell subpopulations in the graft might contribute to chronic GVHD. - Determine the content of natural killer cells, dendritic cells, CD34, CD20, CD14, CD4, CD3, CD8, and naïve and memory T cells in the marrow inocula. Secondary - Assess engraftment and overall survival of these patients. OUTLINE: This is a multicenter study. Patients receive cyclophosphamide IV over 1-2 hours on days -5 to -2 and antithymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo an allogeneic reduced-dose bone marrow transplantation on day 0. Patients also receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or orally twice daily on days -1 to 50, followed by a taper. After completion of study treatment, patients are followed for 100 days and then annually thereafter. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Criteria: DISEASE CHARACTERISTICS: - Diagnosis of aplastic anemia with marrow failure, meeting 2 of the following criteria: - Granulocyte count < 500/mm³ - Corrected reticulocyte count < 1% - Platelet count < 20,000/mm³ - No severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure, including any of the following: - Clonal cytogenetic abnormalities or myelodysplastic syndromes (preleukemia) - Fanconi's anemia - Aplasia secondary to radiotherapy or cytotoxic chemotherapy - Paroxysmal nocturnal hemoglobinuria that has not developed into aplastic anemia - HLA-matched family member available as a donor PATIENT CHARACTERISTICS: - No severe organ toxicities, including any of the following: - Cardiac insufficiency requiring treatment or symptomatic coronary artery disease - Severe hypoxemia, pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted OR mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted - Impaired renal function, defined as creatinine > 2 times upper limit of normal OR creatinine clearance < 60 mL/min - No fungal infections with radiological progression after receipt of amphotericin B or active triazole for > 1 month - No HIV positivity - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No concurrent amphotericin B, antibodies, other investigational medications, or other blood products
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Data Source: ClinicalTrials.gov
Date Processed: September 9, 2010
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