The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Department of Pediatrics, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, Japan
RECRUITINGHematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
Time frame: day 180 after the start of IST
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