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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000083
• Date of registration: 24/07/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Safety assessment of Granulocyte Colony Stimulating Factor:ior LeukoCIM in oncohematologic patients.Phase IV study.
• Scientific title: Safety assessment of Granulocyte Colony Stimulating Factor:ior LeukoCIM in oncohematologic patients.Phase IV study.
• Date of first enrolment: 07/04/2007
• Target sample size: Inclusion of 2 years,sample size is not calculated. Included 914 episodes
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000083-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.Patricia Piedra
• Affiliation: CIMAB S.A

• Name: MD.Patricia Piedra
• Affiliation: CIMAB S.A

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

Age minimum: None
Age maximum: None
Gender: Both

Health Condition(s) or Problem(s) studied

Neutropenia secondary to Chemotherapy and/or Radiotherapy in oncohematologic patients .

Intervention(s)

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 109 / L. Secondary prophylaxis:Patient with neutropenic episodes in previous treatment cycles,was administered ior LeukoCIM 24-72 h 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 109/L. Treatment of febrile neutropenic episodes secondary cycles of QT and/or RT will begin administering the ior LeukoCIM once diagnosed febrile neutropenia (CAN = 1 x 109/L)and for no fever episodes(CAN = 0.5 x 109/L),continuing daily until the CAN recovered to values equal to or greater than 1.5 x 109/L. The treatment is not discontinued,a maximum of 21 days before treatment with ior LeukoCIM if NAC has not reached the value of 1.5 x 109/L.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

IIC RD-089

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable