NCT06362967 The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT
| NCT ID | NCT06362967 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | High Titers of Anti-HLA Antibody (MFI ≥5000) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Subjects to undergo allo-HSCT 2. Age 14-60, No gender, No ethnicity 3. ECOG score ≤ 2 4. Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000 5. No severe organ failure and no active infections 6. Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form Exclusion Criteria: 1. Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas 2. Pregnancy 3. Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment 4. 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 5. Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction 6. Participants in other clinical studies within 3 months 7. 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)
Contact & Investigator
Xiaoyu Zhu, ph.D.
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Frequently Asked Questions
Who can join the NCT06362967 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 60 Years, studying High Titers of Anti-HLA Antibody (MFI ≥5000). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06362967 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06362967 currently recruiting?
Yes, NCT06362967 is actively recruiting participants. Contact the research team at xiaoyuz@ustc.edu.cn for enrollment information.
Where is the NCT06362967 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06362967 clinical trial?
NCT06362967 is sponsored by Anhui Provincial Hospital. The principal investigator is Xiaoyu Zhu, ph.D. at The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial). The trial plans to enroll 30 participants.