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Efficacy and safety of haploidentical transplantation with modified post-transplantation cyclophosphamide for patients with primary aplastic anemia: a prospective, single arm, open lable study

Efficacy and safety of haploidentical transplantation with modified post-transplantation cyclophosphamide for patients with primary aplastic anemia: a prospective, single arm, open lable study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043831
Enrollment
Unknown
Registered
2021-03-04
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

Aplastic anemia

Interventions

PTCY group:receive modified PTCY regimen

Sponsors

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

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Aged 14-60 years; 2) Gender: male or female; 3) Diagnosed with severe aplastic anemia or infusion-dependent non-severe aplastic anemia; 4) Need to receive allogeneic hematopoietic stem cell transplantation without HLA-matched sibling donors or unrelated donors; 5) General condition is acceptable, ECOG score = 50%; 7) Normal liver and kidney function: serum bilirubin <=35umol/L, AST / ALT is below twice the upper limit of normal value, serum creatinine <= 130 umol/L; 8) The subject signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled active infection; 2. Despite proper treatment, cholesterol > 12.95 mmol/l or triglyceride > 5.65 mmol/l and the HIV antibody positive; 3. Pregnant or breastfeeding women; 4. Infected with human immunodeficiency virus (HIV); 5. Other situations that do not meet the enrolled criteria.

Design outcomes

Primary

MeasureTime frame
incidence of III-IV aGVHD;

Secondary

MeasureTime frame
incidence of II-IV aGVHD;rate of engraftment;engraftment time post transplantation;incidence of cGVHD;2-year OS;2-year FFS;2-year GRFS;incidence of infection;incidence of EBV activation;incidence of CMV activation;regimen-related-toxicity;

Countries

China

Contacts

Public ContactYicheng Zhang
yczhang@tjh.tjmu.edu.cn+86 27-83663478

Outcome results

None listed

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