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.

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000084

Enrollment

372

Registered

2009-07-24

Start date

2004-06-07

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia secondary to chemo and/or radiotherapy.

Interventions

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

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion 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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Cuba

Contacts

Public ContactMD.Giselle Saurez

CIMAB S.A

giselle@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026