Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aplastic Anemia
Intervention: Anti-thymocyte globulin (Drug); Cyclophosphamide (Drug); Bone marrow transplantation (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Roswell Park Cancer Institute
Summary
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.
Clinical Details
Official title: Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Primary outcome: Graft failure, graft versus host disease, and survival
Detailed description:
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
Minimum age: N/A.
Maximum age: 59 Years.
Gender(s): Both.
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
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
University of Texas - MD Anderson Cancer Center, 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
Additional Information
Starting date: September 1998
Last updated: October 1, 2008
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