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Interventional study of high-dose IVIg for donor-specific antibody desensitization therapy in haploidentical allogeneic hematopoietic stem cell transplantation

Interventional study of high-dose IVIg for donor-specific antibody desensitization therapy in haploidentical allogeneic hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087788
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-08-20
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

antibody desensitisation group:High-dose IVIg

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years and no gender restriction 2. No diagnosis restriction. Meet the HSCT indications without contraindications 3. With haploidentical donor available. MFI of DSA=5000 within one month before HSCT 4. ECOG score <= 2 5. Normal blood clotting function 6. Regular follow-up, with good compliance, agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Those with severe disease and dysfunction of the heart, brain, liver, kidneys and lungs, active infection or psychological dysfunction to tolerate HSCT 3. Dependence on immuno-suppression therapy due to rheumatologic disease 4. Dependence on anti-tumor drugs due to malignancies 5. Allergic to IVIg or others 6. Second and above transplant recipients 7. Therapy history of clearance of B cells or antibodies such as RTX and proteasome inhibitor within one month before HSCT 8. Not suitable for the study after investigators' evaluation 9. Participants in other clinical studies within 3 months

Design outcomes

Primary

MeasureTime frame
Primary graft failure;

Secondary

MeasureTime frame
Engraftment and engraftment time of neutrophil and platelet;Donor chimerism two weeks after HSCT;acute graft versus host disease;chronic graft versus host disease;reactivation of CMV/EBV;Post-transplantation lymphoproliferative disease;Overall survival;Disease free survival;relapse;Non-relapse mortality;

Countries

China

Contacts

Public ContactYuan Li

Peking University First Hospital

drliyuan75@163.com+86 136 8108 7766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026