Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|