CD20+ B-cell non-Hodgkin lymphoma of Low-Grade (Follicular or small lymphocytic lymphoma ) or aggressive (Diffuse large B-cell lymphoma (DLBCL) or Follicular stage III-IV.
Conditions
Interventions
All patients will be treated with CIMAbior® (Rituximab biosimilar) 375mg/m2, intravenous infusion.
Group 1: CIMABior® as monotherapy during the induction phase. For patients with low grade non-Hodgk
Rituximab
Drug Therapy
CIMAbior
Sponsors
Center of Molecular Immunology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients that fulfill diagnosis criteria 2. Patients who give their informed consent to participate, in writing. 3. Age greater than or equal to 18 years, of any gender. 4. Performance status less than or equal to 2 (ECOG). 5. Patients with laboratory parameters as detailed below: - Hemoglobin= 100 g/L - ALC = 3 x 109 cells/L - ANC = 1,5x109 /L - platelets =100 x 109/L, - TGO/TGP= 2.5 time upper normal limits, - Creatinine and bilirubin = 1.5 time upper normal limits. - Hepatitis B and C negative antigens
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding patients. 2. Patients with evidence of NHL dissemination to the central nervous system. 3. Patients with previous history of demyelinating or inflammatory diseases of the CNS or peripheral . 4. Patients with uncontrolled intercurrent diseases, including, but not limited to: hypertension, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, aortic stenosis, endocarditis, and psychiatric conditions that may limit adherence To the requirements of the test. 5. Patients with HIV positive serology or active hepatitis C or B virus infections. 6. Patients with previous malignancies, except carcinoma in situ of cervix or skin cancer (non-melanoma), correctly treated. 7. Patients with acute allergic conditions, history of severe allergic reactions or attributed to compounds of chemical or biological composition similar to the monoclonal antibody. 8. Patients who are receiving another product under investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with severe adverse events and causal relationship (Definitive, Very Likely, Probable and Possible) with CIMAbior® administration. Measurement time: From the first administration of the product and up to 30 days after the last one. 2. Clinical response: complete remission (RC), complete unconfirmed response (RCu), partial remission (PR), stable disease (ES) or disease progression according to standardized criteria for Non-Hodgkin Lymphoma) . Measuring time: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (AE). Measurement Time: From the first administration of the product and up to 30 days after the last one. - Occurrence of adverse events (AE) in the subject (yes / no) - Description of AE (Type (name of event), - Duration (difference of dates between start and end of AE) - Intensity (mild, moderate, severe, threatening or incapacitating, resulting in death). - Severity of EE (Severe, Not Severe). It is considered serious when: it causes death or threatens the life of the subject, requires / prolongs hospitalization, produces significant or persistent disability / disability, or causes birth defects or congenital anomalies. - Attitude to treatment (No change, dose modification, temporary interruption of treatment, definitive discontinuation of treatment).- Result (Recovered, Improved, Persistent, Sequels). - Causal Relationship (Very Likely, Probable, Possible, Unrelated, Unknown). 2. Overall survival -OS (Time in months from the inclusion of the patient to the objective documentation of death). Measurement Time: until death. 3. Progression-free survival-SLP (Time in months from the inclusion of the patient to the objective documentation of progressive disease or death). Measurement Time: 1 year of follow-up or sooner if progression or death occurs. 4. Response against human anti-chimeric antibody-HACA (antibody titers value). Measuring time: up to 12 weeks after the last infusion if monotherapy, or after the last cycle of chemotherapy if combined treatment. | — |
Countries
Cuba
Contacts
Public ContactYaimarelis Saumell Napoles
Center of Molecular Immunology
Outcome results
None listed