Safety assessment of Granulocyte Colony Stimulating Factor:ior LeukoCIM in oncohematologic patients.Phase IV study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000083

Enrollment

Unknown

Registered

2009-07-24

Start date

2007-04-07

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 Chemotherapy and/or Radiotherapy in oncohematologic patients .

Interventions

Starting dose:LeukoCIM 5µg/Kg/day,subcutaneous. Primary prophylaxis:LeukoCIM the 24-72h at the end of the QT or RT continuing daily for 7-10 days or up to the NAC regained equal or greater than 1.5 x

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who met the diagnostic criteria and/or condition of use. 2.Patients with cytologic diagnosis and/or histologically confirmed cancer of any location that are receiving QT and/or RT. 3.Patients of all ages and both sexes.

Exclusion criteria

Exclusion criteria: 1.Patients with known hypersensitivity to products derived from cells of E.Coli or other preparations of rG-CSF. 2.Patients pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Incidence of Adverse Events (AE) with a causal relationship (IOR LeukoCIM) likely or very likely, measurement time 21 days.	—

Secondary

Measure	Time frame
Recovery of the Absolute Neutrophil Count figures to = 1.5 x 109/L,was assessed using the dichotomous answer yes/no, 21 days measurement time. Time of rercovery the Absolute Neutrophil Count figures to = 1.5 x 109/L, will be assessed on days 21 days measurement time. Biochemical parameters, the values recorded by the units set for each measurement time 21 days. Occurrence of any adverse event was evaluated by yes/no, measurement time: 21 days. Duration of adverse events was assessed in hours and days, measuring time: 21 days. Intensity of adverse events, Light, Moderate, Severe, Very Severe, measurement time: 21 days Result, recovered, improved, or persisted Secuelas, measurement time: 21 days Attitude to treatment, no change, modification of dose or temporary interruption final measurement time: 21 days Causal relationship, very likely, likely, possible, remote, measurement time:21 days	—

Measure

Time frame

Recovery of the Absolute Neutrophil Count figures to = 1.5 x 109/L,was assessed using the dichotomous answer yes/no, 21 days measurement time. Time of rercovery the Absolute Neutrophil Count figures to = 1.5 x 109/L, will be assessed on days 21 days measurement time. Biochemical parameters, the values recorded by the units set for each measurement time 21 days. Occurrence of any adverse event was evaluated by yes/no, measurement time: 21 days. Duration of adverse events was assessed in hours and days, measuring time: 21 days. Intensity of adverse events, Light, Moderate, Severe, Very Severe, measurement time: 21 days Result, recovered, improved, or persisted Secuelas, measurement time: 21 days Attitude to treatment, no change, modification of dose or temporary interruption final measurement time: 21 days Causal relationship, very likely, likely, possible, remote, measurement time:21 days

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Countries

Cuba

Contacts

Public ContactMD.Patricia Piedra

CIMAB S.A

patrip@cim.sld.cu

Outcome results

None listed

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