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 Administration of the next cycle of CT and/or RT at the scheduled time,yes/no:measurement time:Up next cycle.
- Secondary Outcome Measures
Name Time Method Recovery of Absolute Neutrophil Count figures to = 1.5 x 109/L,yes/no,measurement time:21 days. Recovery time of the Absolute Neutrophil Count:start and end dates of treatment,measurement time:21 days. Haematological parameters:values as the units set for each measurement time:21 days. Biochemical parameters: values as the units set for each measurement time:21 days. Occurrence of an adverse event on the subject,yes/no,measurement time:21 days. Duration of adverse event,start and end dates of the adverse events, measurement time:21 days. Intensity of adverse event:Light,Moderate,Severe,Very Severe,measurement time:21 days. Causal relationship: very likely,likely,possible,remote,measurement time:21 days.