Hematologic MalignanciesPAIA-HaploNCT07200583
Protein A Immunoadsorption in Highly Sensitized Haplo-HSCT Patients
An observational study of Hematologic Malignancies and Hematologic Disorders, run by Ting YANG at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Malignancies, Hematologic Disorders, Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Protein A immunoadsorption, Rituximab (optional, in some patients) and Bortezomib (optional, in some patients)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian 350001
Fuzhou, Fujian
About this study
Official title: Efficacy and Safety of Protein A Immunoadsorption-Based Desensitization in Highly Sensitized Haploidentical Hematopoietic Stem Cell Transplantation: A Single-Center Retrospective Study
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.
Read the 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
- Being tested
- Protein A immunoadsorption, Rituximab (optional, in some patients), Bortezomib (optional, in some patients)
- Keywords
- Haploidentical HSCT, Donor-specific anti-HLA antibodies (DSA), Protein A immunoadsorption, Desensitization therapy, Primary graft failure, Poor graft function, Engraftment, Rituximab, Bortezomib
- Medical subject headings
- Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein A immunoadsorptionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Desensitization Group | Highly sensitized haplo-HSCT patients who received protein A immunoadsorption-based desensitization therapy. Receives: Procedure: Protein A immunoadsorption; Drug: Rituximab (optional, in some patients); Drug: Bortezomib (optional, in some patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 28 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start31 May 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ting YANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200583
- Sponsor's protocol ID
- DSA-PAIA-01
- Acronym
- PAIA-Haplo
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Protein A Immunoadsorption-Based Desensitization in Highly Sensitized Haploidentical Hematopoietic Stem Cell Transplantation: A Single-Center Retrospective Study
- ClinicalTrials.gov ID
- NCT07200583
- Acronym / sponsor ID
- PAIA-Haplo / DSA-PAIA-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ting YANGUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desensitization Group | – | Procedure: Protein A immunoadsorption, Drug: Rituximab (optional, in some patients), Drug: Bortezomib (optional, in some patients)Highly sensitized haplo-HSCT patients who received protein A immunoadsorption-based desensitization therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein A immunoadsorptionExtracorporeal therapy performed prior to haploidentical HSCT to remove donor-specific anti-HLA antibodies (DSA) | Procedure or surgery | Desensitization Group |
| Rituximab (optional, in some patients)Anti-CD20 monoclonal antibody occasionally combined with immunoadsorption as part of desensitization strategy | Drug | Desensitization Group |
| Bortezomib (optional, in some patients)Proteasome inhibitor occasionally used in combination with desensitization therapy. | Drug | Desensitization Group |
Primary outcome
Hematopoietic engraftment success rate
Time frame: Within 28 days after transplantation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancies and Hematologic Disorders, run by Ting YANG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematopoietic engraftment success rate (time frame: Within 28 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.