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Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia Clinical research trials and Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia. Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia clinical trial. Human subjects often get the best healthcare available for their Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia  Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia
Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia
For Condition: Aplastic Anemia
Status: No longer recruiting
Sponsor(s): Roswell Park Cancer Institute ,
Synopsis: OBJECTIVES: I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.
Details: PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours. All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide. Patients are followed at day 100, at 6 months, and at 1 year posttransplant.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /59 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Severe aplastic anemia with the following criteria: Hypocellular bone marrow with cellularity less than 20% At least 2 of the following hematologic abnormalities: - Neutrophil count no greater than 500/mm3 - Platelet count no greater than 20,000/mm3 - Reticulocyte count no greater than 50,000/mm3 HLA-identical sibling donor available No clonal cytogenetic abnormalities, paroxysmal nocturnal hemoglobinuria, or myelodysplastic syndrome within 3 months of diagnosis of aplastic anemia No congenital or constitutional aplastic anemia or Fanconi anemia --Patient Characteristics-- Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN Cardiovascular: Normal cardiac function Other: - No uncontrolled infection - No severe concurrent disease - HIV negative - Fertile patients must use effective contraception
Total Enrollment: 224
Location and Contact Information:
Overall Study Official:
PhilipMcCarthy, Study Chair, Roswell Park Cancer Institute
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: 199/14004; RPCI-RP-9804,NCI-G98-1491,IBMTR-1
Study Start Date: September 1998
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004474
Other Aplastic Anemia Studies:
1. Combination Therapy of Severe Aplastic Anemia
2. Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients with Aplastic Anemia
3. A Study to Determine whether Therapy with Daclizumab Will Benefit Patients with Bone Marrow Failure
4. Collection of Blood and Bone Marrow from Normal Volunteers and Patients for Research Purposes
5. Comparing Therapies for the Treatment of Severe Aplastic Anemia
Related Studies:
Other Aplastic Anemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase III Randomized Study of Cyclophosphamide with or without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients with Aplastic Anemia
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