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Sponsored by: |
Roswell Park Cancer Institute |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004474 |
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.
Condition | Intervention | Phase |
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Aplastic Anemia |
Drug: Anti-thymocyte globulin Drug: Cyclophosphamide Procedure: Bone marrow transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia |
Estimated Enrollment: | 224 |
Study Start Date: | September 1998 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive cyclophosphamide IV over 60 minutes on Days -5 to -2 with antithymocyte globulin IV over 4 hours; then, after the last does cycophosphamide, participants will receive a bone marrow transplant over 60 to 120 minutes on Day 0.
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Drug: Anti-thymocyte globulin
Given via IV over 4 hours
Drug: Cyclophosphamide
Given via IV over 60 minutes on Days -5 to -2
Procedure: Bone marrow transplantation
Given on Day 0
|
2: Experimental
Participants will receive cyclophosphamide IV over 60 minutes on Days -5 to -2; then, after the last does cycophosphamide, participants will receive a bone marrow transplant over 60 to 120 minutes on Day 0.
|
Drug: Cyclophosphamide
Given via IV over 60 minutes on Days -5 to -2
Procedure: Bone marrow transplantation
Given on Day 0
|
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.
Ages Eligible for Study: | up to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Midwest Children's Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 |
Responsible Party: | University of Texas - MD Anderson Cancer Center ( Richard Champlin ) |
Study ID Numbers: | 199/14004, RPCI-RP-9804, NCI-G98-1491, IBMTR-1 |
Study First Received: | October 18, 1999 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00004474 History of Changes |
Health Authority: | United States: Federal Government |
Hematologic Disorders Rare Disease |
Immunologic Factors Hematologic Diseases Aplastic Anemia Anemia Rare Diseases Cyclophosphamide Immunosuppressive Agents |
Antilymphocyte Serum Anemia, Aplastic Antineoplastic Agents, Alkylating Bone Marrow Diseases Antirheumatic Agents Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Anemia Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions |
Antilymphocyte Serum Therapeutic Uses Myeloablative Agonists Anemia, Aplastic Antineoplastic Agents, Alkylating Bone Marrow Diseases Antirheumatic Agents Alkylating Agents |