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.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

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.

Secondary indentifying numbers:

IIC RD-050

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Goverment found

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

01/06/2004

Reference number:

19-007-07-B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Andrea Menéndez Veitía,MD.Second degree specialist in Hematology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City,National Institute of Oncology and Radiobiology,Jesús de los Santos Renó,MD.First degree specialist in Oncology. Havana City,Juan Manuel Márquez Pediatrics Hospital,Orestes Chaques Leiva,MD.First degree specialist in Hematology. Pinar del Río,Pepe Portilla Pediatric Hospital,Bárbara Iglesias Castillo,MD.First degree specialist in Oncology. Villa Clara,José Luis Miranda Pediatric Hospital,Berta Vergara Domínguez, MD.MSc.Second degree specialist in Hematology. Granma.Bayamo,General Milanés Tamayo Pediatric Hospital,Fernando Mederos Oviedo,MD.First degree specialist in Hematology. Holguín,Octavio de la Concepción Pediatric Hospital,Ricardo Reyes Avilés.First degree specialist in Pediatric. Santiago de Cuba,Infantil Sur Pediatric Hospital,Noris Corral Pacheco,MD.First degree specialist in Pediatric.

Research ethics committees:

Havana City,National Institute of Oncology and Radiobiology,November 30,2004. Havana City,Juan Manuel Márquez Pediatrics Hospital,August 4,2004. Havana City,National Institute of Hematology and Immunology(IHI),March 3,2004. Pinar del Río,Pepe Portilla Pediatric Hospital,May 31,2004. Villa Clara,José Luis Miranda Pediatric Hospital,June 11,2004. Granma.Bayamo,General Milanés Tamayo Pediatric Hospital,September 8,2004. Holguín,Octavio de la Concepción Pediatric Hospital,June 23,2004. Santiago de Cuba,Infantil Sur Pediatric Hospital,June 23,2004.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

07/06/2004

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

1 year

Maximum age:

18 years

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.

Type of population:

Children

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

372

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MD.Giselle

Last Name:

Saurez

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926,E/19 and 21.Atabey,Playa.

City:

Havana City

Country:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Ext.111

Email :

giselle@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

MD.Giselle

Last Name:

Saurez

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926,e/19 and 21.Atabey,Playa.

City:

Havana City

Country:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Ext.111

Email :

giselle@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000084

Date of Registration in Primary Registry:

2009-07-24

Record Verification Date:

2009-07-20 20:00

Link to the spanish version:

Click here [3]