NCT06837987

Modified Transplantation Regimen and aGVHD Prophylaxis for Severe Aplastic Anemia in the Setting of Allogeneic HSCT.

An Observation of the Safety and Efficacy of a Modified Transplantation Conditioning and aGVHD Prophylaxis for Severe Aplastic Anemia--a Retrospective, Double-center, Single-arm Clinical Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Hematology department of the 920th hospital · Academic / Other
• Sex: All
• Age: 3 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators retrospectively evaluted the safety and efficacy of the modified transplantation conditioning and aGVHD prophylaxis in severe aplastic anemia in 4 transplantation centers.

Detailed description

Aplastic anemia (AA) is a group of myelo-hemopoietic failure syndromes caused by a variety of etiologies. If not intervened, the average expected survival time is less than half a year.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is one of the possible cures for this disease. The success rate of treatment for this disease can be further improved under the previous regimen system. The survival rate reported in the literature is 60%-90%. From Jun. 2020 to Dec. 2023, 72 patients in 4 transplantation center received this modified transplantation system, The investigators designed this clinical trial to retrospectively evaluted the safety and efficacy of the modified transplantation conditioning and aGVHD prophylaxis in severe aplastic anemia in the 4 clinical center.

Conditions

• Aplastic Anaemia
• Transplantation Conditioning

Interventions

Type	Name	Description
OTHER	Modified transplantation system	Modified transplantation conditioning include: Fludarabine 30mg/m2\*6 day, Melphalan 100mg/m2\*1 day, cyclophosphamide 50mg/kg\*2 day.

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-06-30
• Completion: 2025-08-01
• First posted: 2025-02-20
• Last updated: 2025-09-22

Locations

1 site across 1 country: China