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

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:

Secondary indentifying numbers:

IIC RD-089

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Government funds

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 :

24/09/2007

Reference number:

24-075-07B

Principal investigator

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

First name:

MD.Mario Wilford de Leon.Second degree specialist in Internal Medicine.

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,Clinical Surgical Hospital Hermanos Ameijeiras,MD.Calixto Hernandez.First degree specialist in Hematology. Havana City,Institute of Hematology and Immunology,MD.Carlos Hernandez Padron.Second degree specialist in Hematology. Havana Ciy,National Institute of Oncology and Radiobiology,MD.Jesus de los Santos Reno.First degree specialist in Oncology. Havana City,Willian Soler Hospital,MD.Caridad Verdecia Cañizares.Second degree specialist in Oncología. Havana City,Pediatric Hospital Juan Manuel Márquez(JMM),MD.Orestes Chagues Leyva.First degree specialist in Hematology. Pinar del Rio,Clinical Surgical Teaching Hospital Abel Santamaria Cuadrado,MD.Felipe Aponte Espinosa.First degree specialist in Hematology. Pinar del Rio,Pediatric Hospital Pepe Portilla,MD.Barbara Iglesias Castillo.First degree specialist in Oncology. Pinar del Rio,Comandante Pinares Hospital,MD.Anadely Gámez Pérez.First degree specialist in Hematología. Matanzas,Jose Ramon Tabranes Provincial Hospital,MD.Eduardo Santiesteban Álvarez.First degree specialist in Oncology. Matanzas,Faustino Perez Hospital,MD.Nereida Álvarez Vega.First degree specialist in Hematology. Cienfuegos,Gustavo Aldereguia Lima Provincial Hospital,MD.Julio Damaso Fernandez Aguila.Second degree specialist in Hematology. Sancti Spiritus,Camilo Cienfuegos Provincial Hospital,MD.Jose Alberto Rondon Ayala.Second degree specialist in Oncology. Villa Clara,Jose Luis Miranda Pediatric Hospital,MD.Tamara Cedre Hernandez.First degree specialist in Hematology. Villa Clara,Hospital Arnaldo Milián Castro Hospital,MD.Rosa Oliday Ríos Jiménez.First degree specialist in Hematology. Holguin,Octavio de la Concepcion y la Pedraja Hospital,MD.Ricardo Reyes Avilés.First degree specialist in Pediatrie. Santiago de Cuba,Juan Bruno Zayas Hospital,MD.Lidia Clara Suárez Beyríes.First degree specialist in Hematology.

Research ethics committees:

Havana City,Institute of Hematology and Inmunology,June 29 2007. Havana City,National Institute of Oncology and Radiobiology,May 31 2007. Havana City,Clinical Surgical Hospital Hermanos Ameijeiras,April 9,2008. Havana City,Juan Manuel Marquez Pediatric Hospital,January 31,2008. Havana City,Willian Soler Hospital,May 14,2007. Havana City,Center For Surgical Research(CIMEQ),November 27,2006. Pinar del Rio,Pepe Portilla Pediatric Hospital,May 9,2007. Pinar del Rio,Comandante Pinares Hospital,May 16,2007. Pinar del Rio,Abel Santamaria Hospital,Febrary 8,2007. Matanzas,José Ramón López Tabranes Provincial Hospital,November 22,2006. Matanzas,Faustino Perez Hospital,December 4,2006. Cienfuegos,Gustavo Aldereguia Lima Provincial Hospital,December 26,2006. Sancti Spiritus,Camilo Cienfuegos Hospital,December 14,2006. Villa Clara,Arnaldo Milian Hospital,November 24,2006. Villa Clara,Jose Luis Miranda Pediatric Hospital,December 28,2006. Holguin,Octavio de la Concepcion y la Pedraja Hospital,May 28,2007. Santiago de Cuba,Juan Bruno Zayas Hospital,October 4,2007.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

07/04/2007

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 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.

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):

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

Key secondary outcomes:

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

Selection criterias

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

Gender:

Male/Female

Minimum age:

None

Maximum age:

None

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.

Type of population:

Children and Adults

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:

Inclusion of 2 years,sample size is not calculated. Included 914 episodes

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.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

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

City:

Havana City

Country:

Cuba

Zip Code:

11600

Telephone:

537-271-5057 Ext.111

Email :

patrip@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.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

2O6 No.1926 e/19 and 21 Atabey,Playa

City:

Havana City

Country:

Cuba

Zip Code:

11600

Telephone:

537-271-5057 Ext.111

Email :

patrip@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:

RPCEC00000083

Date of Registration in Primary Registry:

2009-07-24

Record Verification Date:

2011-04-27 20:00

Link to the spanish version:

Click here [3]