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.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000084
• Date of registration: 24/07/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 07/06/2004
• Target sample size: 372
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000084-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

Key inclusion & exclusion criteria

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.

Age minimum: 1 year
Age maximum: 18 years
Gender: Both

Health Condition(s) or Problem(s) studied

Neutropenia secondary to chemo and/or radiotherapy.

Intervention(s)

LeukoCIM(Gcsf):5mg/day during 7-10 days,by subcutaneous route as primary and secondary prophylaxis or treatment of neutropenic episodes.

Primary Outcome(s)

Administration of the next cycle of CT and/or RT at the scheduled time,yes/no:measurement time:Up next cycle.

Secondary Outcome(s)

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.

Secondary ID(s)

IIC RD-050

Source(s) of Monetary Support

Goverment found

Secondary Sponsor(s)

No proceed