The Optimization of Conditioning Regimen for HLA Matched HSCT in SAA

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Oct 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying different treatment plans to improve outcomes for patients with severe aplastic anemia (SAA) who are receiving a type of stem cell transplant called hematopoietic stem cell transplantation (HSCT). The researchers want to find out which conditioning regimens—the treatments given before the transplant—work best to minimize complications and improve survival rates. They will compare a few different combinations of medications to see which one helps patients avoid issues like mixed chimerism, where the body doesn’t fully accept the donor cells.

To participate in this trial, you need to be diagnosed with severe or very severe aplastic anemia and have a matched donor, either a sibling or someone unrelated. You also need to be under 50 years old, have no serious infections or organ damage, and be able to give informed consent. If you join, you’ll be monitored closely throughout the study to assess how well the treatment works and to ensure your safety. This trial is currently open for recruitment, and everyone is welcome to apply, regardless of gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed as SAA/vSAA
• • 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:
• • 1. Age \> 50 years old
• • 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