Brief Title
Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Official Title
Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Brief Summary
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.
Detailed 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
The reponse of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Secondary Outcome
The side effect of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
Condition
Aplastic Anemia
Intervention
cyclophosphamide,cyclosporine A
Study Arms / Comparison Groups
moderate-dose cyclophosphomide
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
March 2012
Completion Date
March 2015
Primary Completion Date
March 2015
Eligibility Criteria
Inclusion Criteria:
- Acquired Childhood Severe Aplastic Anemia (SAA)
Exclusion Criteria:
- not Childhood and Acquired Severe Aplastic Anemia
Gender
All
Ages
1 Year - 18 Years
Accepts Healthy Volunteers
No
Contacts
Xiaifan Zhu, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01995331
Organization ID
YL20102601
Responsible Party
Sponsor-Investigator
Study Sponsor
Xiaofan Zhu
Study Sponsor
Xiaifan Zhu, MD, Principal Investigator, Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Verification Date
November 2013