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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-RP-9804 | |||
| NCI-G98-1491 | |||
| IBMTR-1 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-thymocyte globulin | Drug | Given via IV over 4 hours |
| |
| Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| Graft failure, graft versus host disease, and survival | Measured at Day 100, Month 6, and Year 1 post-transplant |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States | ||
| University of Texas - MD Anderson Cancer Center |
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| Drug |
Given via IV over 60 minutes on Days -5 to -2 |
|
| Bone marrow transplantation | Procedure | Given on Day 0 |
|
| Houston |
| Texas |
| 77030-4009 |
| United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| D006402 | Hematologic Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D003520 | Cyclophosphamide |
| D016026 | Bone Marrow Transplantation |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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