Status:
COMPLETED
The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Ruijin Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE4
Brief Summary
Aim: To evaluate if additional cord blood transfusion could accelerate the hematopoietic reconstitution in severe aplastic anemia(SAA) patients receiving immunosuppressive therapy (IST). Study design...
Detailed Description
Eligible patients should be under 60 years old with confirmed SAA, without HLA matched siblings and previous ATG treatment history. Patients will be excluded if they present any fatal disease, includi...
Eligibility Criteria
Inclusion
- 1．Diagnosis of AA confirmed by bone marrow aspirate and biopsy, myelodysplastic syndrome and paroxysmal nocturnal hemoglobinuria were excluded. To confirm severe AA, the patient must fulfill at least two of the criteria: i) ANC\<0.5×109/L,ii)PLT\<20×109/L and iii) Ret\<20×109/L ,in addition, ANC\<0.5×109/L must be included.
- 2\. Under 60 years old, male or female.
- 3\. No HLA matched siblings.
- 4\. No previous ATG treatment history.
- 5\. Performance status score no more than 2 (ECOG criteria).
- 6．Adequate organ function as defined by the following criteria:ALT, AST and total serum bilirubin \<2×ULN (upper limit of normal) Serum creatinine and BUN \<1.25×ULN.
- 7\. Adequate cardiac function without acute myocardial infarction, arrhythmia or atrioventricular block, heart failure, active rheumatic heart disease and cardiac dilatation.
- 8．Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- 9\. Willingness and ability to comly with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion
- Presence of any condition inappropriate for HSCT.
- Presence of any fatal disease, including respiratory failure, heart failure, liver or kidney function failure et al.
- 3．Severely allergic to biologic products.
- 4．Pregnancy or breastfeeding.
- 5．Current treatment on another clinical trail.
- 6．Any other condition the investigator judged the patient inappropriate for entry into this study.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02745717
Start Date
January 1 2016
End Date
December 1 2021
Last Update
March 17 2023
Active Locations (1)
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1
Shanghai general hospital, Shanghai Jiaotong university school of medicine
Shanghai, Shanghai Municipality, China, 200080