Protein A Immunoadsorption in Highly Sensitized Haplo-HSCT Patients

Sponsor
Ting YANG
Study ID
NCT07200583
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
50 participants (actual)

Arms

  • Arm: Desensitization Group
    Highly sensitized haplo-HSCT patients who received protein A immunoadsorption-based desensitization therapy.

Primary Outcome Measure

Hematopoietic engraftment success rate [ Time Frame: Within 28 days after transplantation ]

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