A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
Overview
- Phase
- Phase 3
- Intervention
- Thymoglobulin
- Conditions
- Acquired Aplastic Anemia.
- Sponsor
- Nagoya University
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
- Last Updated
- 10 years ago
Overview
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.
Investigators
Hideki Muramatsu
Assistant Professor
Nagoya University
Eligibility Criteria
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
- Not provided
Arms & Interventions
2.5 mg/kg/day of Thymoglobulin for 5 days
2.5 mg/kg/day of Thymoglobulin for 5 days
Intervention: Thymoglobulin
3.5 mg/kg/day of Thymoglobulin for 5 days
3.5 mg/kg/day of Thymoglobulin for 5 days
Intervention: Thymoglobulin
Outcomes
Primary Outcomes
Hematologic 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