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To evaluate the hematological responses based on the response assessment criteria when AMG531 is subcutaneous (SC)-administered with anti-human thymocyte immunoglobulin (ATG) + ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.
Enrollment
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Inclusion criteria
Exclusion criteria
Previously treated with ATG, CsA, or Alemtuzumab;
Diagnosed as having congenital AA (Fanconi anemia, congenital dyskeratosis, etc.);
Diagnosed as having AML or chronic myelomonocytic leukemia;
Concurrent thrombocytopenia of other etiologies (e.g., MDS, ITP, cirrhosis);
Concurrent active infection not adequately responding to appropriate therapy;
Concurrent clinically significant illness(es) items which are deemed by the Investigator to be likely to affect the study conduct and assessments.
Having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent.
Concurrent PNH
Having Grade 2 or higher bone marrow reticulin based on Bone Marrow Pathology (2nd edition) ;
History of chromosome aberrations discovered in bone marrow cells.
Having blast cells > 2% in bone marrow;
Positive for anti-human immunodeficiency virus (HIV) antibody;
Receiving prophylactic or therapeutic treatment for hepatitis type B
Positive for hepatitis C virus (HCV) antibody, and HCV infection being confirmed
Planned hematopoietic stem cell transplantation during the study;
Systemic treatment with any of the following medication for the treatment of AA within 4 weeks before Day 1, however, excluding their use as premedication:
Pregnant or breastfeeding women, or women willing to become pregnant;
Other conditions unsuitable for participation in the study in the opinion of the Investigator.
Primary purpose
Allocation
Interventional model
Masking
17 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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