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Efficacy and safety of optimized post-cyclophosphamide preconditioning regimen (PTCy regimen) for haploid allogenic hematopoietic stem cell transplantation in patients with severe aplastic anemia

Efficacy and safety of optimized post-cyclophosphamide preconditioning regimen (PTCy regimen) for haploid allogenic hematopoietic stem cell transplantation in patients with severe aplastic anemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087734
Enrollment
Unknown
Registered
2024-08-02
Start date
2024-08-10
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

aplastic anemia

Interventions

Trial group:In the pre-treatment process, the drug (BU) is only used for one day in the trial group
Control group:In the pre-treatment process, the drug (BU) is used for standard two days in the control group

Sponsors

Huazhong University of Science Tongji Hospital, Tongji Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-60; 2) Gender: male or female; 3) Related allogeneic hematopoietic stem cell transplantation healthy donor; 4) Weight >=40kg; 5) The general condition is OK, ECOG score=50%; 7) Normal liver and kidney function: blood bilirubin <=35µmol/L, AST/ALT less than 2 times the upper limit of normal value, serum creatinine <=130µmol/L; 8) Subjects sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Unrelated allogeneic hematopoietic stem cell transplantation; 2) ECOG >2; 3) Severe infection before mobilization that was not controlled; 4) Patients with renal insufficiency (creatinine>=176.8lmol/l); 5) Hepatic insufficiency (total bilirubin>34.2umol/L, ALT, AST>=3 times the upper limit of normal); 6) Patients with cardiac insufficiency (left ventricular ejection fraction12.95mmol/l or triglyceride>5.65mmol/l and positive human immunodeficiency virus seroreaction despite appropriate treatment; 8) Pregnant or lactating women; 9) Known infection with human immunodeficiency virus (HIV); 10) Other situations that do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
the incidence of engraftment;

Secondary

MeasureTime frame
overall survival rate;failure-free-survival rate;

Countries

China

Contacts

Public ContactDonghua Zhang

Huazhong University of Science Tongji Hospital, Tongji Medical College

andie_fu@163.com+86 27 8366 2830

Outcome results

None listed

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