Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia

Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia

Sponsors

Lead sponsor: Chinese Academy of Medical Sciences

Source Chinese Academy of Medical Sciences
Brief Summary

Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.

Overall Status Unknown status
Start Date December 2010
Completion Date November 2015
Primary Completion Date December 2013
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia 1 years
Secondary Outcome
Measure Time Frame
the relapse rate with different doses of ATG to treat child severe aplastic anemia 4-10 years
Enrollment 100
Condition
Intervention

Intervention type: Drug

Intervention name: ATG

Description: Drug ATG:2.5mg/kg/d or 3.75mg/kg/d for 5 days; Drug Cyclosporine A (CSA):3-10mg/kg/d ,Adjust the dose to maintain drug levels between 150 and 300ng/ml; Drug prednisone:1mg/kg/d,d1-21 from the first dosage of ATG; Drug Granulocyte Colony-Stimulating Factor(G-CSF):5ug/kg/d until absolute neutrophil count (ANC) >1×109/L.

Arm group label: high dose ATG,low dose ATG

Eligibility

Criteria:

Inclusion Criteria:

- clinical diagnosis of childhood acquired severe aplastic anemia(SAA)

Exclusion Criteria:

- clinical diagnosis of no childhood acquired severe aplastic anemia(SAA)

Gender: All

Minimum age: 1 Year

Maximum age: 18 Years

Healthy volunteers: No

Overall Contact

Last name: Xiaofan Zhu, MD

Phone: +86 22 23909001

Email: [email protected]

Location
facility status contact Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences Xiaofan Zhu, MD +86 22 23909001 [email protected]
Location Countries

China

Verification Date

December 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Chinese Academy of Medical Sciences

Investigator full name: Xiaofan Zhu

Investigator title: Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: high dose ATG,low dose ATG

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov