NCT07200583

Protein A Immunoadsorption in Highly Sensitized Haplo-HSCT Patients

Efficacy and Safety of Protein A Immunoadsorption-Based Desensitization in Highly Sensitized Haploidentical Hematopoietic Stem Cell Transplantation: A Single-Center Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Ting YANG · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study reviews patients who received haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Some patients develop donor-specific antibodies (DSA), which can block engraftment and cause transplant failure. Before transplant, a treatment called protein A immunoadsorption (a blood purification method to remove antibodies) was used, sometimes with additional medications. The study aims to see whether this approach lowers antibody levels, increases the chance of successful engraftment, reduces complications such as infections or graft failure, and improves short-term survival. The results may help guide safer and more effective transplants for highly sensitized patients.

Detailed description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective, and often the only curative, treatment for many malignant and non-malignant hematologic diseases. Haploidentical HSCT (haplo-HSCT) has become a widely available option, but the presence of donor-specific anti-HLA antibodies (DSA) in recipients significantly increases the risk of graft rejection and primary graft failure. High DSA levels, particularly with mean fluorescence intensity (MFI) ≥5000, have been shown to result in substantially higher rates of engraftment failure compared with patients without DSA. To address this problem, desensitization strategies are needed. Protein A immunoadsorption is an extracorporeal therapy that selectively removes antibodies from the blood and may reduce the risk of graft failure. In this single-center, retrospective study, we will evaluate the efficacy and safety of protein A immunoadsorption-based desensitization, sometimes combined with agents such as rituximab or bortezomib, in highly sensitized haplo-HSCT patients. The primary outcome is hematopoietic engraftment success rate. Secondary outcomes include changes in DSA levels (MFI reduction, clearance, or negativity), incidence of major transplant-related complications (primary graft failure, poor graft function, severe infections, acute graft-versus-host disease), and survival outcomes (overall survival and disease-free survival at 100 days and 1 year). Risk factor analysis will also be performed to identify predictors of engraftment failure or poor survival. Because this is a retrospective observational study, no additional interventions will be introduced, and all data will be collected from medical records. This research is expected to provide real-world evidence to optimize desensitization strategies and improve clinical outcomes in highly sensitized haplo-HSCT recipients.

Conditions

• Hematologic Malignancies
• Hematologic Disorders
• Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
• Graft Failure

Interventions

Type	Name	Description
PROCEDURE	Protein A immunoadsorption	Extracorporeal therapy performed prior to haploidentical HSCT to remove donor-specific anti-HLA antibodies (DSA)
DRUG	Rituximab (optional, in some patients)	Anti-CD20 monoclonal antibody occasionally combined with immunoadsorption as part of desensitization strategy
DRUG	Bortezomib (optional, in some patients)	Proteasome inhibitor occasionally used in combination with desensitization therapy.

Timeline

• Start date: 2025-05-31
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2025-10-01
• Last updated: 2025-11-18

Locations

1 site across 1 country: China