Relapsed or refractory indolent B-cell non-Hodgkin lymphoma
Conditions
Interventions
Study group RituxCIM (Rituximab biosimilar): 375mg/m2 weekly, for 4 weeks (intravenous infusion), following the same methodology of administration of the commercial Rituximab.
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients that fulfill diagnosis criteria 2. Age greater than or equal to 18 years, of any gender. 3. Performance status less than or equal to 2 (ECOG). 4. Able and willing to give written informed consent. 5. Patients could have received any previous specific therapy (Chemotherapy/radiotherapy), provided that such treatment had ended, at least, 4 weeks before being included in the study. 6. Patients comply with the requirements of the clinical laboratory: Hemoglobin= 100 g/L ALC = 3 x 10?9 cells/L ANC = 1,5x10?9 /L platelets =100 x 10?9/L, TGO/TGP= 2.5 time upper normal limits creatinine and bilirubin = 1.5 time upper normal limits.
Exclusion criteria
Exclusion criteria: 1. Presence of brain metastasis. 2. Diagnosis of follicular lymphoma III B (clasiffied by WHO). 3. Patients who have been previously treated with corticosteroids, two weeks before inclusion 4. Uncontrolled hypertension 5. History of demyelinated diseases or inflammatory perfiric or CNS. 6. Pregnancy or breastfeeding. 7. Human Immunodeficiency Virus (HIV) seropositivity 8. History of other cancer, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix. 9. Acute allergy or history of severe allergic reactions or autoimmune disease. 10. Patients on any other experimental product. 11. Patients who have been previously treated with comercial Rituximab 12. History of allergy to chemical or biologicl compounds similar to the experimental product. 13. Patients who have any decompensated concomitant disease, including but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, aortic stenosis, endocarditis and psychiatric illnesses that may limit adherence to the requirements of the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response (complete remission (CR), unconfirmed complete response (Rcu) or partial remission (PR)). Measuring Time: at 6 weeks after four doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 1 year of follow-up or progression date or death date. Time to progression (TTP).Time in months from clinical response date until it objectively documented progressive disease or death. Measuring time: 1 year of follow-up or progression date or death date. Pharmacokinetics (Plasma concentration, maximal concentration, plasma half-life of a drug (T ½), Clearance). Measuring time: at 1st and 4th dose. Immune Response (Labeling with mAb, B-cell markers, serum immunoglobulin levels, levels of circulating immune complexes, complement hemolytic activity CH50). Measuring time: before each dose of RitxCIM, at 6 weeks after 4 doses. B cells depletion (Absolute counts of B cells in peripheral blood). Measuring time: before each dose of RitxCIM, at 6 weeks after 4 doses. Incidence of Adverse Events (AE) (type (name of AE), Duration (difference between start date and the end date of the AE), Intensity (Mild, Moderate, Severe, which threatens or incapacitates, Death), Gravity (Serious, Not serious), Attitude regarding treatment (No change, Dose modification, temporary interruption of treatment, final interruption of treatment), Outcome (Recovered, Improved, Persists, Sequelae) causality relationship (Final, Very Likely, Likely, Possible, Not related, Unknown)). Measuring time: in every administration until to complete 1 year. | — |
Countries
Cuba
Contacts
Public ContactPatricia Hernandez Casaña
Center of Molecular Immunology
Outcome results
None listed