The Optimization of Conditioning Regimen for HLA Matched HSCT in SAA
NCT ID: NCT06069180
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
160 participants
INTERVENTIONAL
2023-11-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Busulfan included group
The conditioning regimens were Bu/Flu/Cy/ATG or Bu/Cy/ATG, depending on the patient's risk factors of regimen related cardiotoxicity.
Busulfan
Conditioning regimens were Bu/Flu/Cy/ATG or Bu/Cy/ATG, depending on the patient's risk factors of regimen related cardiotoxicity.
Control group
The conditioning regimens were Flu/Cy/ATG or Cy/ATG, depending on the patient's risk factors of regimen related cardiotoxicity.
Flu/Cy/ATG or Cy/ATG
Conditioning regimens were Flu/Cy/ATG or Cy/ATG, depending on the patient's risk factors of regimen related cardiotoxicity.
Interventions
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Busulfan
Conditioning regimens were Bu/Flu/Cy/ATG or Bu/Cy/ATG, depending on the patient's risk factors of regimen related cardiotoxicity.
Flu/Cy/ATG or Cy/ATG
Conditioning regimens were Flu/Cy/ATG or Cy/ATG, depending on the patient's risk factors of regimen related cardiotoxicity.
Eligibility Criteria
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Inclusion Criteria
2. Indication for hematopoietic stem cell transplantation
3. Available HLA matched sibling or unrelated donor
4. No active infection
5. No serious organ damage: liver and kidney function (ALT and AST \< 2.5 times normal value, normal renal function, no cardiac insufficiency)
6. Signed informed consent
7. High risk factors of mixed chimerism, at least one of the following
1. Age \< 18 years old
2. Ferritin level ≥2500ng/ml before transplantation
Exclusion Criteria
2. ECOG≥3
3. Active infections that were difficult to control
4. Severe liver and kidney dysfunction
5. Mental illness
6. Not signing the informed consent
7. pregnant or lactating women
8. Any condition considered by the investigators to be unsuitable for enrollment
1 Year
50 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Xiao-Jun Huang
Professor
Principal Investigators
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Xiao-Jun Huang
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023PHB232-001
Identifier Type: -
Identifier Source: org_study_id
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