Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
This trial is active, not recruiting.
|Start date||March 2012|
|End date||March 2015|
|Trial size||30 participants|
|Trial identifier||NCT01995331, YL20102601|
Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors associated with life-threatening complications. High-dose cyclophosphamide has been found to yield a complete response (CR) in adults and children with SAA.However, the optimal dosage of cyclophosphamide for patients in childhood remains unclear. So we explore the ideal dosage of cyclophosphamide for the treatment of children with SAA.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The reponse of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
time frame: 36 months
The side effect of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
time frame: 36 months
Male or female participants from 1 year up to 18 years old.
Inclusion Criteria: - Acquired Childhood Severe Aplastic Anemia (SAA) Exclusion Criteria: - not Childhood and Acquired Severe Aplastic Anemia
|Official title||Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia|
|Principal investigator||Xiaifan Zhu, MD|
|Description||Tisdale et al. (2000,2002) attempted to compare immunosuppression using ATG/CSA with high-dose cyclophosphamide (50 mg/kg/d for 4 consecutive days) plus CSA in a randomized trial of newly diagnosed adults with SAA. Both groups received CSA as part of the treatment regimen. However, the trial was terminated prematurely due to excessive morbidity among the patients treated in the cyclophosphamide arm. They documented that invasive fungal infections were severe among the cyclophosphamide group. Between January 2008 through May 2009, in our department, nine pediatric patients with a diagnosis of SAA were enrolled a study with lower dose of cyclophosphamide with 30mg/kg/day for 4 consecutive days and combination with CSA, this study shows promise for children with severe aplastic anemia.Now we want explore the dosage of cyclophosphamide.|
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