Protein A Immunoadsorption in Highly Sensitized Haplo-HSCT Patients

NCT07200583 | Completed

• 1 other identifier: DSA-PAIA-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Haploidentical HSCT; Donor-specific anti-HLA antibodies (DSA); Protein A immunoadsorption; Desensitization therapy; Primary graft failure; Poor graft function; Engraftment; Rituximab; Bortezomib

Outcome Measures

Primary Outcomes (1)

• Hematopoietic engraftment success rate

  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

  Within 28 days after transplantation

Study Arms (1)

Desensitization Group

Highly sensitized haplo-HSCT patients who received protein A immunoadsorption-based desensitization therapy.

Procedure: Protein A immunoadsorption; Drug: Rituximab (optional, in some patients); Drug: Bortezomib (optional, in some patients)

Interventions

Protein A immunoadsorption PROCEDURE

Extracorporeal therapy performed prior to haploidentical HSCT to remove donor-specific anti-HLA antibodies (DSA)

Desensitization Group

Rituximab (optional, in some patients) DRUG

Anti-CD20 monoclonal antibody occasionally combined with immunoadsorption as part of desensitization strategy

Desensitization Group

Bortezomib (optional, in some patients) DRUG

Proteasome inhibitor occasionally used in combination with desensitization therapy.

Desensitization Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Highly sensitized patients with donor-specific anti-HLA antibodies (DSA positive) who underwent haploidentical hematopoietic stem cell transplantation at the First Affiliated Hospital of Fujian Medical University and received protein A immunoadsorption-based desensitization therapy prior to transplant.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ting YANG: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian 350001

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Hematologic Diseases

Interventions

Rituximab; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: May 31, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)