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Comparison of double-dose anti-CD25 monoclonal antibody and single-dose anti-CD25 monoclonal antibody combined with methotrexate for aGVHD prevention in haploidentical stem cell transplantation

Comparison of double-dose anti-CD25 monoclonal antibody and single-dose anti-CD25 monoclonal antibody combined with methotrexate for aGVHD prevention in haploidentical stem cell transplantation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060184
Enrollment
Unknown
Registered
2022-05-21
Start date
2022-05-09
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Acute leukemia or myelodysplastic syndrome

Interventions

control group:A single dose of CD25 mab combined with MTX was used
experimental group:A double dose of CD25 monoclonal antibody was used

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with acute leukemia /MDS in our hospital; 2. Patients aged 18 to 65 years; 3. Comorbidity index (HCT-CI) <=4; 4. Patients should commit to follow the study procedures and cooperate throughout the study.

Exclusion criteria

Exclusion criteria: 1. HLA-matched hematopoietic stem cell transplantation; 2. Unrelated donors; 3. Cyclophosphamide is used in the transplantation regimen to prevent GVHD; 4. Patient is in pregnancy or lactation; 5. Estimated survival time of the patient <6 months.

Design outcomes

Primary

MeasureTime frame
the incidence of aGVHD;

Secondary

MeasureTime frame
the incidence of cGVHD;the incidence of oral ulcer;the incidence of diarrhea;the incidence ofCMV/EBV reactivation;the incidence of relapse;the cost of antibiotic use;the incidence of GVHD/relapse-free survival;

Countries

China

Contacts

Public ContactXia Linghui

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Linghuixia@hust.edu.cn+86 18627733999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026