|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Roswell Park Cancer Institute |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004474 |
Purpose
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 |
|
Aplastic Anemia |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Procedure: Bone Marrow Transplantation |
Phase III |
| MedlinePlus related topics: | Anemia Bone Marrow Transplantation Cancer |
| ChemIDplus related topics: | Cyclophosphamide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Estimated Enrollment: | 224 |
| Study Start Date: | September 1998 |
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
| 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:
Contacts and Locations| 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 | |||||
| Roswell Park Cancer Institute |
| Study Chair: | Philip L. McCarthy, Jr. | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | 199/14004, RPCI-RP-9804, NCI-G98-1491, IBMTR-1 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004474 |
| Health Authority: | Unspecified |
|
|
|
|
|