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A prospective single-arm clinical study exploring low-dose splenic area irradiation combined with plasma exchange, anti-CD20 antibody to reduce HLA antibody titer in patients with high-titer HLA antibody in haploidentical hematopoietic stem cell transplantation to improve the prognosis.

A prospective single-arm clinical study exploring low-dose splenic area irradiation combined with plasma exchange, anti-CD20 antibody to reduce HLA antibody titer in patients with high-titer HLA antibody in haploidentical hematopoietic stem cell transplantation to improve the prognosis.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051456
Enrollment
Unknown
Registered
2021-09-24
Start date
2020-06-01
Completion date
Unknown
Last updated
2022-06-20

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

Conditions

Allogeneic hematopoietic stem cell transplantation

Interventions

1:splenic radiotherapy

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing haploidentical stem cell transplantation; 2. Aged 18 to 60 years old; 3. ECOG score 0-1; 4. Those who have been screened positive of HLA-I or II antibodies before transplantation (MFI value >10000); 5. The informed consent forms are signed voluntarily by the subjects participated in this study.

Exclusion criteria

Exclusion criteria: 1. Patients combined with other progressing malignant diseases; 2. Patients combined with serious and uncontrolled infections or serious chronic diseases and was accessed not fit for chemotherapy; 3. Heart failure: Ejection fraction (EF) =2 mg/dl, AST> 2.5 ULN, serum creatinine (SCr)> 2.5 mg/dl; 5. Patients who Refuse to be involved in the study.

Design outcomes

Primary

MeasureTime frame
MFI of HLA antibody sites: <4000;Rate of successful implantation;

Secondary

MeasureTime frame
Time of engraftment of platelet;Time of engraftment of neutrophil;Overall survival of 3 years;

Countries

China

Contacts

Public ContactDepei Wu

The First Affiliated Hospital of Soochow University

drwudepei@163.com+86 13951102021

Outcome results

None listed

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