Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | — | UNRESOLVED | — |
| Graft Failure | — | UNRESOLVED | — |
| Hematologic Disorders | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib (optional, in some patients) | Drug | Bortezomib | ALIAS |
| Protein A immunoadsorption | Procedure | — | UNRESOLVED |
| Rituximab (optional, in some patients) | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Desensitization Group
- description
- Highly sensitized haplo-HSCT patients who received protein A immunoadsorption-based desensitization therapy.
- interventionNames
- Procedure: Protein A immunoadsorption
- Drug: Rituximab (optional, in some patients)
- Drug: Bortezomib (optional, in some patients)
Primary outcomes (1)
- measure
- Hematopoietic engraftment success rate
- timeFrame
- Within 28 days after transplantation
- description
- Proportion of patients achieving engraftment after haploidentical HSCT, defined as: Neutrophil recovery ≥0.5 × 10\^9/L for 3 consecutive days; Platelet recovery ≥20 × 10\^9/L without transfusion for 3 consecutive days
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Patients who received haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) from a related donor (≥5/10 HLA match). Presence of donor-specific anti-HLA antibodies (DSA) before transplantation, with mean fluorescence intensity (MFI) above the positive threshold. Underwent desensitization therapy mainly based on protein A immunoadsorption (with or without additional agents such as rituximab or bortezomib), with complete treatment records. Successfully completed transplantation at the study center and had at least 100 days of follow-up. Exclusion Criteria: Missing critical data (e.g., incomplete DSA results, desensitization details, or follow-up outcomes). Inadequate follow-up (patients lost to follow-up or transferred to another hospital without accessible records). Patients who did not complete desensitization or did not undergo HSCT infusion.
References
Publications (0)
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