Effect and Safety of ior® EPOCIM in patients with Non-Hodking Lymphoma treated with anthracyclines.

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:

Evaluation of the Effect and Safety of ior® EPOCIM use in the prevention of cardiotoxicity in patients with Non-Hodking Lymphoma treated with anthracyclines.

Secondary indentifying numbers:

IIC-RD EC126

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology

Source(s) of monetary or material support:

Center of Molecular Immunology

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 Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

26/02/2010

Reference number:

05.024.09.B

Principal investigator

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

First name:

Liermis

Midle name:

Michael

Last name:

Dita Salabert

Medical Specialty :

Hematology and Integral General Medicine

Affiliation:

Gustavo Aldereguía Lima Hospital (GAL)

Postal address:

51 A street , Ave. 5 de Septiembre.

City:

Cienfuegos

Country:

Cuba

Zip Code:

55100

Telephone:

+53-043591100

Email address:

liermis.dita@gal.sld.cu [1]

ivis@cencec.sld.cu [2]

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,Hermanos Ameijeiras Hospital,Aramis Núñez Quintana,MD.First degree specialist in Hematology.

Santiago de Cuba, Juan Bruno Zayas Hospital, Beatriz Ondina de la Uz Ruega, MD. First degree specialist in Hematology

Research ethics committees:

Havana City,Hermanos Ameijeiras Hospital,october 05,2009.

Cienfuegos,Gustavo Aldereguía Lima Hospital,july 15,2009. Santiago de Cuba, Juan Bruno Zayas Hospital, April 20, 2011.

Santiago de Cuba, Juan Bruno Zayas Hospital (JBZ), 20 de Abril de 2011.

Recruitment status

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

Recruitment status:

Suspended

Date of first enrollment:

13/07/2010

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:

Patients with Non-Hodking Lymphoma

Intervention(s):

Experimental group: CHOP scheme (cyclophosphamide (C),doxorubicin (H),vincristine (O), prednisone (P))+ EPOCIM CHOP scheme (cyclophosphamide (C), doxorubicin (H), vincristine (O), prednisone (P)) every 14, 21 or 28 days, in dependent of clinical conditions of the patient and his treatment response until 6 or 8 cycles. It´s considering 450 mg accumulative doxorubicin dose. Treatment with 2 doses of ior® EPOCIM 40 000 IU each. The study drug will be administered intravenously, diluted in 100 ml of dextrose 5 % or saline infusion 0.9% for 30 minutes. The first dose will be administered 1 hour before infusion of doxorubicin. The second dose will be administered 24 hours after infusion of doxorubicin. It will be repeated in each cycle of chemotherapy. Control Group: CHOP scheme (cyclophosphamide (C),doxorubicin (H),vincristine (O), prednisone (P)) CHOP scheme (cyclophosphamide (C), doxorubicin (H), vincristine (O), prednisone (P)) every 14, 21 or 28 days, in dependent of clinical conditions of the patient and his treatment response until 6 or 8 cycles. It´s considering 450 mg accumulative doxorubicin dose.

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):

Diastolic dysfunction (Yes/No).Dependent of the Deceleration time (DT),the value ejection/shortening (E/A)and the Isovolumic relaxation time (IVRT). Measurement time:in each cycle of chemotherapy ,4 weeks after finish chemotherapy , and every 4 months for a year after finish treatment . Septal and lateral speed by tissue doppler. Measurement time:in each cycle of chemotherapy ,4 weeks after finish chemotherapy , and every 4 months for a year after finish treatment . Septal and lateral E/e´relationship. Measurement time:in each cycle of chemotherapy ,4 weeks after finish chemotherapy , and every 4 months for a year after finish treatment .

Key secondary outcomes:

Related to the effect: - Systolic function using the ejection fraction of left ventricular (LVEF)and the fractional shortening (FAC) - Isovolumetric ejection total index (TEI index) - - Ventricular diameter (diastolic and systolic)in mm - Interventricular septum diameter (diastolic and systolic) in mm - Posterior wall diameter (diastolic and systolic ) in mm - Atrial diameter (systolic)in mm Measurement time :in each cycle of chemotherapy ,4 weeks after finish chemotherapy ,and every 4 months for a year after finish treatment. - Heart damage enzyme(T Troponin and natriuretic peptid).Measurement time:in each cycle of chemotherapy ,4 weeks after finish chemotherapy Apearance of clinical signs and symptoms associated cardiotoxicity (description of the symptoms) - Time to onset of cardiotoxic event(days between inclusion date and date of the event if it appears ) - Hemoglobin using units establish in clinical sites. Measurement time:in each cycle of chemotherapy ,4 weeks after finish chemotherapy - Hematocrit using units establish in clinical sites. Measurement time:in each cycle of chemotherapy ,4 weeks after finish chemotherapy Related Safety: Occurrence of some adverse events (AE)in the subject. -Description of AE.Name of the event -Duration of AE.(Difference between the beginning date and the finish date of the event) -Intensity of AE (Slight , Moderate, Severe) -Severity of AE (Severe/Serious,Not severe/Not serious) -Attitude to study treatment (Unchanged,Dose modification ,Temporary discontinuation of study treatment,Permanent discontinuation of study treatment) -Outcome of AE (Recovered,Improved,Persist,Persist,Sequelae) -Relationship causality (Definitive,Very likely,Probable,Possible,Not related,Unknown) -Onco-specific Treatment response (CHOP)(Complete Response ,Partial Response,No response ,Resistance/Progressive Disease) Measurement time:in each cycle of chemotherapy,4 weeks after finish chemotherapy and every 4 months for a year after finish treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

N/A(No limit)

Inclusion criteria:

.Patients who met the diagnostic criteria. .Patients of either sex with age greater than or equal to 18 years. .Patients who give informed consent to participate in writing. .Patients with hemoglobin below 13 g/dl.

Exclusion criteria:

.Patients with uncontrolled hypertension. .Patients with known risk or a history of venous or arterial thromboembolic disease. .Severe cardiovascular disease:unstable angina,heart failure,aortic stenosis,endocarditis. .Patients with poor acoustic window. .Severe cerebrovascular disease. .Septic embolism. .Chronic myeloproliferative diseases. .Patients with known hypersensitivity to products derived from higher cells or hypersensitivity to human albumin.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Other

Other design:

Fleming Secuencial Desing (two stages)

Phase:

Target sample size:

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:

Giselle

Last Name:

Saurez Martinez

Specialty:

Integral General Medicine and Farmacology

Affiliation:

CIMAB SA.

Postal Address:

206 Street,No.1926 e/19 and 21

City:

Havana City

Country:

Cuba

Zip Code:

10600

Telephone:

(53)7-271-50-57 ext.111

Email :

giselle@cim.sld.cu [3]

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:

Giselle

Last Name:

Saurez Martinez

Specialty:

Integral General Medicine and Pharmacology

Affiliation:

CIMAB SA.

Postal Address:

206.Street, N.1926 e/19 and 21

City:

Havana City

Country:

Cuba

Zip Code:

10600

Telephone:

(53)7-271-50-57 ext.111

Email :

giselle@cim.sld.cu [3]

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:

RPCEC00000096

Date of Registration in Primary Registry:

2010-06-11

Record Verification Date:

2015/07/17

Next update date:

2016/07/17

Link to the spanish version:

Click here [4]