Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
|ClinicalTrials.gov Identifier: NCT01995331|
Recruitment Status : Unknown
Verified November 2013 by Xiaofan Zhu, Chinese Academy of Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia||Drug: cyclophosphamide,cyclosporine A||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2015|
Drug: cyclophosphamide,cyclosporine A
Drug,cyclophosphamide,cyclophosphamide (30 mg/kg/day) administered intravenously (IV) over 1 hr for 4 consecutive days Drug,cyclosporine A,5mg-12mg/kg.d,CSA was administered orally 40 days after the fourth dose of cyclophosphamide and maintained for 3 years. The dose of CSA was adjusted to maintain trough drug concentration above 150 μg/L and peak drug concentration above 300 μg/L.
Drug, human granulocyte colony-stimulating factor (rhG-CSF), 5 μg/kg/day subcutaneously starting 24 hrs after the fourth dose of cyclophosphamide, and it was withdrawed when ANC was >1×109/L.
Other Name: Drug,Mesnaum
- The reponse of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia [ Time Frame: 36 months ]Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count >100×109/L, and ANC>1.5×109/L. Partial response (PR) was defined as transfusion independence, reticulocyte count >30×109/L, platelet count >30×109/L, and ANC >0.5×109/L above the baseline. Persistence of transfusion requirement or death was evidence of no response (NR).
- The side effect of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia [ Time Frame: 36 months ]
To report the death rate and the death cause , the infection rate and the pathogenic bacteria, especialy the fungal infection rate.
To report other toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995331
|Department of Pediatrics,Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College|
|Tianjin, Tianjin, China, 300020|
|Principal Investigator:||Xiaifan Zhu, MD||Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences|