Acquired Aplastic Anemia.
Conditions
Brief summary
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.
Interventions
DRUGThymoglobulin
Sponsors
Nagoya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 69 Years
Healthy volunteers
No
Inclusion criteria
* Acquired aplastic anemia * Age: younger than 70 years old * Severity: SAA, VSAA. * Interval between diagnosis and registration \<6 months. * Written informed consent from the caretakers and/or whenever possible consent from the patient.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST. | day 180 after the start of IST |
Countries
Japan
Contacts
Primary ContactSeiji Kojima, MD., PhD.
Backup ContactHideki Muramatsu, MD., PhD.
Outcome results
None listed