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Efficacy and Safety of Recombinant Humanized Anti-CD25 Monoclonal Antibody Combination Regimen for Severe Acute GVHD Prophylaxis after High-Risk Haploidentical Allogeneic HSCT: A Study

Recombinant humanized anti-CD25 monoclonal antibody Combined with CsA, MTX, MMF and ATG for Prophylaxis of Severe Acute Graft-versus-Host Disease after High-Risk Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Single-Arm, Single-Center Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116132
Enrollment
Unknown
Registered
2026-01-06
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Acute Graft-versus-Host Disease (aGVHD)

Interventions

Experimental Group:Recombinant Humanized Anti-CD25 Monoclonal Antibody+ CsA + MTX + MMF + ATG

Sponsors

The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Male or female, aged 18-65 years; 2.Patients with malignant hematological diseases eligible for and scheduled to undergo haploidentical allogeneic hematopoietic stem cell transplantation; 3.Assessed as high-risk for severe aGVHD based on a predictive model; 4.ECOG performance status 0-2; 5.Expected survival >=3 months; 6.No severe comorbidities; 7.Voluntary participation with signed informed consent, good compliance, and willingness to complete follow-up.

Exclusion criteria

Exclusion criteria: 1.History of severe allergic reactions, especially allergy to components of the study drug; 2.Prior receipt of hematopoietic stem cell transplantation; 3.Presence of active infection (including bacterial, viral, or fungal); 4.HIV-positive patients, or patients with uncontrolled chronic hepatitis B virus (HBsAg-positive) or hepatitis C virus (anti-HCV) infection; 5.Participation in another drug clinical study within 4 weeks prior to screening; 6.Pregnant or lactating female patients, or patients unable to take effective contraceptive measures throughout the entire trial period; 7.Patients with severe concomitant diseases or other comorbid conditions that would interfere with planned treatment, or any other condition unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of severe aGVHD (grade III-IV) within 100 days post-transplantation;—

Secondary

MeasureTime frame
cGVHD incidence;Safety;Overall survival (OS);Incidence of aGVHD (any grade) within 100 days post-transplantation;Infection incidence;—

Countries

China

Contacts

Public ContactShuangnian Xu

The First Affiliated Hospital of Army Medical University of the People's Liberation Army of China

xushuangnian1985@163.com+86 13650596553

Outcome results

None listed

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