Status:
UNKNOWN
The Optimization of Conditioning Regimen for HLA Matched HSCT in SAA
Lead Sponsor:
Peking University People's Hospital
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
1-50 years
Phase:
PHASE4
Brief Summary
Hematopoietic stem cell transplantation (HSCT) from a human leukocyte antigen (HLA) -matched donor is an effective option for severe aplastic anemia (SAA), but there is no standardized and recommended...
Eligibility Criteria
Inclusion
- Diagnosed as SAA/vSAA
- Indication for hematopoietic stem cell transplantation
- Available HLA matched sibling or unrelated donor
- No active infection
- No serious organ damage: liver and kidney function (ALT and AST \< 2.5 times normal value, normal renal function, no cardiac insufficiency)
- Signed informed consent
- High risk factors of mixed chimerism, at least one of the following
- Age \< 18 years old
- Ferritin level ≥2500ng/ml before transplantation
Exclusion
- Age \> 50 years old
- ECOG≥3
- Active infections that were difficult to control
- Severe liver and kidney dysfunction
- Mental illness
- Not signing the informed consent
- pregnant or lactating women
- Any condition considered by the investigators to be unsuitable for enrollment
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06069180
Start Date
November 15 2023
End Date
December 31 2025
Last Update
November 18 2023
Active Locations (1)
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1
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044