A Phase 3 interventional study of Anti-thymocyte globulin and Cyclophosphamide in Aplastic Anemia, sponsored by Roswell Park Cancer Institute. Completed at 4 sites in United States. Open to participants aged Up to 59 Years. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Roswell Park Cancer Institute · Phase 3, Interventional, and Treatment
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 224 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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.
Drug: Anti-thymocyte globulin · Drug: Cyclophosphamide · Procedure: Bone marrow transplantation
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 · Procedure: Bone marrow transplantation
Given via IV over 4 hours
Given via IV over 60 minutes on Days -5 to -2
Given on Day 0
Graft failure, graft versus host disease, and survival
Time frame: Measured at Day 100, Month 6, and Year 1 post-transplant
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute