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

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000096
• Date of registration: 11/06/2010
• Primary sponsor: Center of Molecular Immunology
• Public title: Effect and Safety of ior® EPOCIM in patients with Non-Hodking Lymphoma treated with anthracyclines.
• 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.
• Date of first enrolment: 13/07/2010
• Target sample size: 88
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000096-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Other Purpose: Treatment Other design features: Fleming Secuencial Desing (two stages)

Countries of recruitment

Cuba

Contacts

• Name: Giselle Sáurez Martínez.MD
• Affiliation: CIMAB SA.

• Name: Giselle Sáurez Martínez.MD
• Affiliation: CIMAB SA.

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: N/A(No limit)
Gender: Both

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.

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 .

Secondary Outcome(s)

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.

Secondary ID(s)

IIC-RD EC126

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable