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Home > "P" Clinical Trials Conditions > Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients with Aplastic Anemia  Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients with Aplastic Anemia
Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients with Aplastic Anemia
For Condition: Aplastic Anemia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of California, Los Angeles
Synopsis: OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia. II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.
Details: PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow transplantation. Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate. All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.
Eligibility:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: /55 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Severe aplastic anemia with 2 of the following criteria: Polymorphonuclear neutrophils no more than 0.5 x 10 to the ninth/L Platelets no more than 20 x 10 to the ninth/L Reticulocytes no more than 30 x 10 to the ninth/L Hypocellular bone marrow Related donor aged 6 weeks or more, matching at least 4 of 6 HLA A, B, and DRI loci, as follows: HLA-identical family member for patients aged less than 40 years HLA-nonidentical family member for patients aged less than 55 years failing antithymocyte globulin or other immunosuppressive therapy The following eligible for transplantation as initial therapy: Patients aged less than 40 years with HLA-matched donor Patients aged 40-45 years with HLA-identical donor No neoplastic or preneoplastic evolution --Patient Characteristics-- Age: Under 40 (55 if ATG failure) Hepatic: No severe liver dysfunction Renal: No severe renal dysfunction Cardiovascular: No severe cardiac dysfunction Other: No other organ dysfunction that would compromise survival after transplant No HIV infection
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
MaryTerrito, Study Chair, University of California, Los Angeles
Center for Health Sciences
Los Angeles, California, 90024-1714
United States
Additional Information:
Study ID Numbers: 199/11863; UCLA-94020602
Study Start Date: February 1995
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004323
Other Aplastic Anemia Studies:
1. Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients with Aplastic Anemia
2. Collection of Blood from Patients with Pancytopenia
3. Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Transplantation for Patients with Hematologic Malignancies or Bone Marrow Failure States
4. Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia
5. Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic Anemia
Related Studies:
Other Aplastic Anemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients with Aplastic Anemia
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