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View Clinical Trial (Medical Research Study)
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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 - NCT00343785-94609 (Clinical Trial 146125)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy146125.aspx
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| City: |
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Oakland |
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State:
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CA |
| Zip Code: |
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94609 |
| Conditions: |
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Graft Versus Host Disease - Nonmalignant Neoplasm |
| Purpose: |
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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.
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| Study summary: |
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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: |
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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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| Study is available at: |
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Children's Hospital and Research Center Oakland
Oakland, CA 94609
United States
Primary Contact:
Clinical Trial Office - Children's Hospital and Research Cente
Phone: 510-450-7600 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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