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

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ClinicalTrials.gov Identifier: NCT01997372
Recruitment Status : Unknown
Verified December 2013 by Xiaofan Zhu, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Xiaofan Zhu, 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.

Condition or disease Intervention/treatment Phase
Severe Aplastic Anemia Drug: ATG Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia
Study Start Date : December 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high dose ATG,low dose ATG Drug: ATG
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.




Primary Outcome Measures :
  1. the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia [ Time Frame: 1 years ]
    Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count >100×109/L, and ANC>1.5×109/L. Partial response (PR) was defined as transfusion independence, reticulocyte count >30×109/L, platelet count >20×109/L, and ANC >0.5×109/L above the baseline. Persistence of transfusion requirement or death was evidence of no response (NR).


Secondary Outcome Measures :
  1. the relapse rate with different doses of ATG to treat child severe aplastic anemia [ Time Frame: 4-10 years ]
    relapse was defined as transfusion dependence again; or progressed to paroxysmal nocturnal hemoglobinuria (PNH) /acute myeloid leukemia/myelodysplasia syndrome (MDS); or CSA dependence



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997372


Contacts
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Contact: Xiaofan Zhu, MD +86 22 23909001 zhuxiaof@yahoo.com.cn

Locations
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China, Tianjin
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences Recruiting
Tianjin, Tianjin, China, 300020
Contact: Xiaofan Zhu, MD    +86 22 23909001    zhuxiaof@yahoo.com.cn   
Sponsors and Collaborators
Chinese Academy of Medical Sciences

Publications of Results:
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Responsible Party: Xiaofan Zhu, Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01997372     History of Changes
Other Study ID Numbers: Xzhu
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013
Keywords provided by Xiaofan Zhu, Chinese Academy of Medical Sciences:
ATG
SAA
immunosuppressive treatment
cyclosporine
Additional relevant MeSH terms:
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Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors