High Titers of Anti-HLA Antibody (MFI ≥5000)Phase 2NCT06362967
The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT
A Phase 2 study testing Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG in people with High Titers of Anti-HLA Antibody (MFI ≥5000), run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- High Titers of Anti-HLA Antibody (MFI ≥5000)
- What is being tested?
- Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects to undergo allo-HSCT
- Age 14-60, No gender, No ethnicity
- ECOG score ≤ 2
- Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000
- No severe organ failure and no active infections
- Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form
Who cannot join
- Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas
- Pregnancy
- Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment
- Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk
- Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction
- Participants in other clinical studies within 3 months
- Those whom the investigator considers unsuitable for enrolment (e.g., subjects will not be able to adhere to examinations and treatments due to financial or other issues)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230036
Xiaoyu Zhu, ph.D, 15255456091, xiaoyuz@ustc.cn
Yue Wu, M.D, 13805601119, wuyue20160701@163.com
About this study
Official title: The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Centre, Single-Arm, Phase II Clinical Study
Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation
Read the detailed description
Approximately 10-21% of allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients have non-specific or donor-specific anti-HLA antibodies (DSAs) prior to transplantation. Patients with combined DSAs and mean fluorescence intensity (MFI) ≥ 5000 can lead to a significantly higher incidence of primary graft failure and graft dysfunction after transplantation, and increased transplant-related mortality (TRM). Meanwhile, a retrospective study at our centre found that patients with high titre non-specific antibodies (MFI ≥ 5000) present before cord blood transplantation had significantly higher TRM in the early post-transplantation period. Therefore, our centre intends to conduct a single-arm prospective cohort study to explore whether the desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG before transplantation in allogeneic hematopoietic stem cell transplantation patients with high titres of anti-HLA antibodies can lower the antibody titres in the patient's body, reduce the incidence of transplant-related complications, and improve the prognosis of transplantation.
- Being tested
- Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG
- Keywords
- immunoadsorption or plasma exchange；rituximab；high-dose IVIG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIGCombination product
Also called Intravenous Immunoglobin
For allogeneic haematopoietic stem cell transplantation patients with high titers of anti-HLA antibodies present in the body, a desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG is used prior to transplantation.
| Study group | Role | What they receive |
|---|---|---|
| antibody desensitisation group | Experimental | Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG Receives: Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment
Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment
Measured: at the end of desensitation treatment
Secondary outcomes (11)
Incidence of primary graft failure
Incidence of primary graft failure
Measured: 42 days
Incidence of TRM after allo-HSCT
Incidence of TRM after allo-HSCT
Measured: 100 days
Incidence of ineffective platelet transfusion after allo-HSCT
Incidence of ineffective platelet transfusion after allo-HSCT
Measured: 100 days
Cumulative incidence of neutrophil engraftment after allo-HSCT
Cumulative incidence of neutrophil engraftment after allo-HSCT cumulative incidence of neutrophil engraftment after allo-HSCT
Measured: 42 dyas
Cumulative incidence of II-IV° acute GVHD
Cumulative incidence of II-IV° acute GVHD
Measured: 100 days
Cumulative incidence of relapse at 1 year post-transplant
Cumulative incidence of relapse at 1 year post-transplant
Measured: 360 days
Probability of overall survival post transplantation
Probability of overall survival post transplantation
Measured: 360 days
Incidence of allergies and allergic reactions
Incidence of allergies and allergic reactions
Measured: at the end of desensitation treatment
Incidence of haemorrhagic events
Incidence of haemorrhagic events
Measured: at the end of desensitation treatment
Incidence of viral, bacterial and fungal infections
Incidence of viral, bacterial and fungal infections
Measured: at the end of desensitation treatment
Incidence of hypocalcaemia
Incidence of hypocalcaemia
Measured: at the end of desensitation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Titers of Anti-HLA Antibody (MFI ≥5000)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Zhu, ph.D., Principal investigator, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362967
- Sponsor's protocol ID
- Anti-HLA antibody
- Status last verified
- Dec 2024
- First submitted
- 9 Apr 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Immunosorbent or Plasma Exchange Combined With Rituximab and High-dose IVIG for Patients With High Titers of Anti-HLA Antibodies Prior to Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Centre, Single-Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06362967
- Acronym / sponsor ID
- Anti-HLA antibody
- Keywords
- immunoadsorption or plasma exchange；rituximab；high-dose IVIG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Apr 2024 (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.
Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation
Detailed description
Approximately 10-21% of allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients have non-specific or donor-specific anti-HLA antibodies (DSAs) prior to transplantation. Patients with combined DSAs and mean fluorescence intensity (MFI) ≥ 5000 can lead to a significantly higher incidence of primary graft failure and graft dysfunction after transplantation, and increased transplant-related mortality (TRM). Meanwhile, a retrospective study at our centre found that patients with high titre non-specific antibodies (MFI ≥ 5000) present before cord blood transplantation had significantly higher TRM in the early post-transplantation period. Therefore, our centre intends to conduct a single-arm prospective cohort study to explore whether the desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG before transplantation in allogeneic hematopoietic stem cell transplantation patients with high titres of anti-HLA antibodies can lower the antibody titres in the patient's body, reduce the incidence of transplant-related complications, and improve the prognosis of transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antibody desensitisation group | Experimental | Combination Product: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIGImmunoadsorption or plasma exchange combined with rituximab, high-dose IVIG |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects to undergo allo-HSCT
- Age 14-60, No gender, No ethnicity
- ECOG score ≤ 2
- Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000
- No severe organ failure and no active infections
Key exclusion criteria (7 listed)
- Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas
- Pregnancy
- Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment
- Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk
- Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction
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 |
|---|---|---|
| Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIGAlso: Intravenous ImmunoglobinFor allogeneic haematopoietic stem cell transplantation patients with high titers of anti-HLA antibodies present in the body, a desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG is used prior to transplantation. | Combination product | antibody desensitisation group |
Primary outcome
Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment
Time frame: at the end of desensitation treatment
Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment
11 secondary outcomes
Incidence of primary graft failure
Time frame: 42 days
Incidence of TRM after allo-HSCT
Time frame: 100 days
Incidence of ineffective platelet transfusion after allo-HSCT
Time frame: 100 days
Cumulative incidence of neutrophil engraftment after allo-HSCT
Time frame: 42 dyas
Cumulative incidence of II-IV° acute GVHD
Time frame: 100 days
Cumulative incidence of relapse at 1 year post-transplant
Time frame: 360 days
Probability of overall survival post transplantation
Time frame: 360 days
Incidence of allergies and allergic reactions
Time frame: at the end of desensitation treatment
Incidence of haemorrhagic events
Time frame: at the end of desensitation treatment
Incidence of viral, bacterial and fungal infections
Time frame: at the end of desensitation treatment
Incidence of hypocalcaemia
Time frame: at the end of desensitation treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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.
Xiaoyu Zhu, ph.D. principal investigator
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG in people with High Titers of Anti-HLA Antibody (MFI ≥5000), run by Anhui Provincial Hospital 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, ph.D. (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment (time frame: at the end of desensitation treatment). 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 Dec 2024.