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Allogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective Trial

Allogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023509
Enrollment
Unknown
Registered
2019-05-31
Start date
2017-01-01
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

aplastic anemia,Refractory Cytopenia of Childhood

Interventions

1:Fludarabine150 mg/m2 +Cyclophosphamide200 mg/kg+ Thymoglobuline10mg/kg
2:Fludarabine200 mg/m2 +Cyclophosphamide120 mg/kg+ Thymoglobuline10mg/kg+300cGy TBI
3:Fludarabine200 mg/m2 +Cyclophosphamide120 mg/kg+ Thymoglobuline10mg/kg+ Busulfan 8mg/kg

Sponsors

Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Severe aplastic anemia,very severe aplastic anemia,transfusion denpendent non-severe aplastic anemia or refractory cytopenia of childhood; 2. Younger than 18 years old; 3. Sign the informed consent document.

Exclusion criteria

Exclusion criteria: 1. Congenital bone marrow failure; 2. Hypoplastic myelodysplastic syndrome with cytogenetic abnormality as Monosomy 7; 3. Severe organ dysfunction:Alanine transaminase (ALT) more than 3x upper limit of normal,Serum bilirubin greater than 2 x upper limit of normal,Creatinine Clearance less than 60 ml/min,Left ventricular ejection fraction less than 50%; 4. Active infection.

Design outcomes

Primary

MeasureTime frame
failure free survival;

Secondary

MeasureTime frame
overall survival;Engraftment;incidence of acute graft versus host disease;incidence of chronic graft versus host disease;

Countries

China

Contacts

Public ContactCHEN JING

Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of Medicine

chenjingscmc@hotmail.com+86 021-38626161-82032

Outcome results

None listed

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