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Home > "S" Clinical Trials Conditions > Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders  Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
For Condition: Shwachman syndrome,Graft Versus Host Disease,Osteopetrosis,Neutropenia,Red-Cell Aplasia, Pure
Status: Recruiting
Sponsor(s): Fairview University Medical Center ,
Synopsis: OBJECTIVES: I. Deliver potential curative therapy with unrelated donor bone marrow transplantation in patients with Kostman's neutropenia, Shwachman's neutropenia, Diamond-Blackfan anemia, or autosomal recessive osteopetrosis. II. Determine the rate of engraftment following transplantation of nongenotypic identical bone marrow with partial lymphocyte depletion using a preparative regimen consisting of busulfan, cyclophosphamide, anti-thymocyte globulin and radiotherapy in this patient population. III. Determine the incidence of acute and chronic graft vs host disease, relapse, and three year survival in this patient population treated with this regimen.
Details: PROTOCOL OUTLINE: Patients receive busulfan orally or IV every 6 hours on Days -6 and -5, cyclophosphamide IV over 2 hours on Days -4 and -3 and total body irradiation on Day -2. Patients receive anti-thymocyte globulin IV over 2 hours twice daily on Days -2 and -1, and Days 1 and 2 posttransplantation. Patients undergo T-cell depleted unrelated allogeneic bone marrow transplantation (ABMT) on Day 0. Patients undergoing unrelated cord blood transplantation receive undepleted ABMT. Following ABMT, patients receive immunosuppressive therapy consisting of cyclosporine IV over 2 hours every 8-12 hours and then orally beginning on Day -3 and continuing until Day 180, and methylprednisolone IV every 12 hours on Days 5-19. Patients are followed at Days 21, 100, and then annually.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /18 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of autosomal recessive osteopetrosis OR Bone marrow failure syndrome unresponsive to available therapy including but not limited to: Diamond-Blackfan anemia Evidence of steroid resistance requiring greater than 6 transfusions annually despite steroid therapy; Evidence of developing aplasia or myelodysplasia; Previously diagnosed Shwachman Diamond syndrome with the following clinical characteristics: exocrine pancreatic insufficiency, growth retardation, metaphyseal dysostosis, neutropenia, Kostman's neutropenia; diagnosis by bone marrow aspiration; no evidence of acute leukemia Failed prior filgrastim (G-CSF) therapy for Shwachman Diamond syndrome or Kostman's neutropenia; inability to maintain an absolute neutrophil count greater than 750/mm3 OR recurrent infections despite G-CSF therapy resulting in life threatening infections or repeated hospitalizations of less than 4 per year No aplastic anemia Serologically HLA A, B, or DR matched unrelated bone marrow donor OR One antigen mismatched unrelated donor --Patient Characteristics-- Performance status: Karnofsky 70-100% Hepatic: bilirubin no greater than 3.0 mg/dL; ALT no greater than 150 U/L; no active hepatitis Renal: GFR at least 30% predicted Cardiovascular: Left ejection fraction at least 45% Pulmonary: FVC and FEV at least 70%; oxygen saturation at least 94% Other: No severe, stable neurologic impairment; HIV-negative; not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulOrchard, Study Chair, Fairview University Medical Center
Fairview University Medical Center *Recruiting*
Minneapolis, Minnesota,
United States
Recruiting Paul Orchard
Additional Information:
Study ID Numbers: 199/15103; UMN-MT-1995-13,UMN-MT-9513,UMN-MT-2000-18
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005895
Other Graft Versus Host Disease Studies:
1. Post marketing surveillance study of Actimmune in patients with severe, malignant osteopetrosis.
2. Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis
3. Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
Related Studies:
Other Graft Versus Host Disease Clinical Trials
Other Minnesota Clinical Trials
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Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders
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