Patients with Non-Hodking Lymphoma
Conditions
Interventions
Experimental group: CHOP scheme (cyclophosphamide (C),doxorubicin (H),vincristine (O), prednisone (P))+ EPOCIM CHOP scheme (cyclophosphamide (C), doxorubicin (H), vincristine (O), prednisone (P)) ever
Sponsors
Center of Molecular Immunology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactGiselle Saurez Martinez
CIMAB SA.
Outcome results
None listed