Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
N/A
59 Years
Both
Aplastic Anemia
Trial Information
Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Outcome Measure:
Graft failure, graft versus host disease, and survival
Outcome Time Frame:
Measured at Day 100, Month 6, and Year 1 post-transplant
Safety Issue:
Yes
Authority:
United States: Federal Government
Study ID:
199/14004
NCT ID:
NCT00004474
Start Date:
September 1998
Completion Date:
August 2007
Related Keywords:
- Aplastic Anemia
- Hematologic Disorders
- Rare Disease
- Anemia
- Anemia, Aplastic
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
