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Efficacy of different dosage of antithymocyte globulin in HLA-matched allogeneic hematopoietic stem cell transplantation for thalassemia major treatment: a multi-center, open, randomized, controlled clinical study

Efficacy of different dosage of antithymocyte globulin in HLA-matched allogeneic hematopoietic stem cell transplantation for thalassemia major treatment: a multi-center, open, randomized, controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15005779
Enrollment
Unknown
Registered
2014-12-29
Start date
2015-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

thalassemia major

Interventions

control group:Busulfan+fludarabine+cyclophosphamiade+antithymocyte globulin(10mg/kg)
experimental group :Busulfan+fludarabine+cyclophosphamiade+antithymocyte globulin(8mg/kg)

Sponsors

First Affilited Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age: 2 to 18 years old; 2. Gender: Male or female; 3. Thalassemia major; 4. HLA-matched related hematopoietic stem cell transplantation; 5. no sereve infection; 6. In good general condition, ECOG score less than 1; 7. Normal heart function: ejection fraction more than 50%; 8. Normal liver and renal function: Serum bilirubin less than 35umol/L, AST/ALT less than 2 times the upper limit, serum creatinine under 2 times the upper limit; 9. Enrolled subjects or their families signed informed consent.

Exclusion criteria

Exclusion criteria: 1. severe infection uncontrolled before transplantation; 2. severe allergic on Antithymocyte globulin (anaphylactic shock or laryngeal edema); 3. unrelated allogeneic hematopoietic stem cell transplantation;Hyplotype allogeneic hematopoietic stem cell transplantation; second transplantation, reduced-intensisty transplantation; 4. Cardiac dysfunction (ejection fraction less than 50%); 5. Renal insufficiency (serum creatinine more than 130umol/L); 6. Hepatic dysfunction (total bilirubin more than 34umol/L, ALT, AST more than 2 times the upper limit of normal); 7. Previously history of allogeneic hematopoietic stem cell transplantation; 8. Other circumstances which do not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
over-survival;disease-free survival;

Countries

China

Contacts

Public ContactYongrong Lai
laiyongrong@263.net+86 13517711828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026