Overview

This trial is active, not recruiting.

Condition aplastic anemia
Treatment cyclophosphamide,cyclosporine a
Phase phase 4
Sponsor Xiaofan Zhu
Start date March 2012
End date March 2015
Trial size 30 participants
Trial identifier NCT01995331, YL20102601

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
cyclophosphamide,cyclosporine a Drug,Mesnaum
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.

Primary Outcomes

Measure
The reponse of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
time frame: 36 months

Secondary Outcomes

Measure
The side effect of Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia
time frame: 36 months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences.