Status:
UNKNOWN
Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic Anemia
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Aplastic Anemia
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to reduce the regimen related toxicities and transplantation related mortality after allogeneic stem cell transplantation in adult acquired aplastic anemia (AA), the trial...
Detailed Description
TREATMENT PLAN * The patients will be admitted to laminar air flow room. * The patients will have triple lumen Hickman central venous catheter (CVC) placed. Chest X-ray should be taken after CVC plac...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Severe aplastic anemia
- Severe aplastic anemia (SAA) is defined as a hypocellular bone marrow (cellularity\<25%) and two or more of the following: granulocyte count \<500/ml, platelet count \<20,000/ml, and corrected reticulocyte count \<1.0%
- Very severe aplastic anemia (VSAA) is defined as the criteria for SAA plus a granulocyte count \<200/ml
- Patients should be 15 years of age or older, but younger than 65 years.
- The performance status of the patients should be 70 or over by Karnofsky performance scale (see Appendix I).
- 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 echocardiogram).
- Exclusion criteria:
- Patients should not have major illness or organ failure.
- 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.
- Hypoplastic myelodysplastic syndrome
- Paroxysmal nocturnal hemoglobinuria
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01145976
Start Date
March 1 2010
End Date
February 1 2016
Last Update
September 7 2012
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 138-736