Status:
UNKNOWN
A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic Anemia
Lead Sponsor:
Yizhou Zheng
Conditions:
Aplastic Anemia
Eligibility:
All Genders
6-70 years
Phase:
PHASE2
Brief Summary
Severe acquired aplastic anaemia (SAA) is a bone marrow failure disease characterized by pancytopenia and a hypocellular bone marrow. The corn pathophysiological mechanism is the destruction of hemato...
Detailed Description
During the treatment period, rATG is administered at a dose of 1.97 mg/kg/day for 9 days by slow intravenous infusion. CSA is administered orally at a dose of 3 mg/kg qod, and Levamisole was administe...
Eligibility Criteria
Inclusion
- Newly diagnosed SAA (according to the standard criteria)
- Bone marrow cellularity less than 30% (excluding lymphocytes)
- At least two of the following: Absolute neutrophil count less than 500/ uL; Platelet count less than 20,000/ uL; Absolute reticulocyte count less than 20,000/ uL.
- Age greater than or equal to 6 years old
Exclusion
- Serum creatinine greater than 2.5 mg/dL
- Underlying carcinoma (except local cervical, basal cell, squamous cell)
- Prior immunosuppressive therapy with ATG, antilymphocyte globulin (ALG), or high dose cyclophosphamide.
- Current pregnancy or lactation or unwillingness to take oral contraceptives or use an effective method of birth control.
- Diagnosis of Fanconi anemia or other congenital bone marrow failure syndromes
- Evidence of a clonal disorder on cytogenetics. Patients with super severe neutropenia (ANC less than 200/uL) will not be excluded if results of cytogenetics are not available or pending.
- Underlying immunodeficiency state including seropositivity for HIV
- Inability to understand the investigational nature of the study or give informed consent
- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient s ability to tolerate protocol therapy, or that death within 7-10 days is likely.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02203396
Start Date
August 1 2014
End Date
September 1 2017
Last Update
May 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020