Impact of the Granulocytes Colony-Stimulating Factor (ior-LeukoCIM) in primary and secondary prophylaxis and post chemotherapy and/or radiotherapy neutropenia in oncohematological pediatric patients.
Phase 4
Completed
- Conditions
- eutropenia secondary to chemo and/or radiotherapy.
- Registration Number
- RPCEC00000084
- Lead Sponsor
- Center of Molecular Immunology(CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 372
Inclusion Criteria
1.Patients that fulfilled the diagnostic and/or condition of use criteria. 2.Patients with cytological and/or histological diagnosis of cancer of any localization that were receiving CT and/or RT. 3.Patients whose parents or tutors granted written consent for participation in the study. 4.Patients under 18 years old. 5.Will include patients of both sexes.
Exclusion Criteria
1.Patients with known hypersensitivity to products derived from E.Coli cells or other preparations of rG-CSF. 2.Acute or serious allergic status. 3.Patients with great tumor volumes in mediastinum in which concomitant CT and RT are needed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method