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Safety and efficacy of combination dose-adjusted ATG and anti-CD25 antibody on prophylaxis of GVHD in patients with haplo-HSCT

Safety and efficacy of combination dose-adjusted ATG and anti-CD25 antibody on prophylaxis of GVHD in patients with haplo-HSCT

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069733
Enrollment
Unknown
Registered
2023-03-24
Start date
2023-03-25
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Graft Versus Host Disease

Interventions

exprerimental group:mostomatine 0.2g/m2×1d, busulfan 0.8mg/kg q6h×3d, cyclophosphamide 1.8g/m2×2d, cytarabine 2g/m2 q12h×2d, ATG 2.5mg/kg×3d, CD25 monoclonal antibody 1mg/kg×1d
Control group:mostomatine 0.2g/m2×1d, busulfan 0.8mg/kg q6h×3d, cyclophosphamide 1.8g/m2×2d, cytarabine 2g/m2 q12h×2d, ATG 2.5mg/kg×4d

Sponsors

Second Affiliated Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Allogeneic hematopoietic stem cell transplant recipients who receive haploid pretreatment protocol, and the pretreatment protocol is determined by the investigator; 2) Age= 18 years old, and = 60 years old; 3) KPS score > 60 points or ECOG score of 0~2 points; 4) The expected survival is greater than 3 months; 5) Those without serious damage to the function of important organs of the whole body; 6) Fully understand and inform the research and sign the informed consent form (ICF); Willing to follow and able to complete all trial procedures.

Exclusion criteria

Exclusion criteria: 1) Severe cardiac, renal or hepatic insufficiency; 2) Those who need treatment for other malignant tumors; 3) pregnant or lactating women; 4) Those who cannot follow up as scheduled; 5) Patients who cannot guarantee the completion of the necessary treatment plan and follow-up observation. 6) Researchers believe that other reasons are not suitable for clinical trial personnel.

Design outcomes

Primary

MeasureTime frame
Acute Graft Versus Host Disease;

Secondary

MeasureTime frame
Hematopoietic reconstitution time after allogeneic hematopoietic stem cell transplantation;Level 3-4 aGVHD, cGVHD;infection rate;Total survival rate;Disease free survival rate;Transplant related mortality;Karnosky Quality of Life Assessment;

Countries

China

Contacts

Public ContactZhu Lidan

Medical center of hemaotology, xinqiao hospital, Army medicl university

25566770@qq.com13752928889

Outcome results

None listed

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