Status:
COMPLETED
Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Bone Marrow Failure Syndromes
Eligibility:
All Genders
15-60 years
Phase:
PHASE3
Brief Summary
Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoietic cell tra...
Detailed Description
This is a prospective, randomized, non-blind study. Conditioning therapy will start on day -5 in patients who are randomized to receive Cy+ATG. Hydration with 0.45% NaCl at 6 liters/24 hours will be ...
Eligibility Criteria
Inclusion
- Patients with bone marrow failure syndrome.
- Written informed consent must be obtained from the patients and donors.
- Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor who is 60 years or less.
- Patients should be 15 years of age or older, but younger than 60 years.
- The performance status of the patients should be 70 or over by Karnofsky performance scale (see Appendix I).
- Patients should not have major illness or organ failure.
- Patients must have adequate hepatic function (bilirubin less than 2 mg/dl, AST and ALT less than three times the upper normal limit).
- Patients must have adequate renal function (creatinine less than 2.0 mg/dl).
- Patients must have adequate cardiac function (ejection fraction \> 45% on MUGA scan).
- Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlikely, and making informed consent impossible.
- Patients must not be in pregnancy.
Exclusion
- Patients should have major illness or organ failure
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00774527
Start Date
March 1 2003
End Date
January 1 2011
Last Update
February 17 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736