Diffuse large B-cell lymphoma, newly diagnosed
Conditions
Interventions
Group A (Experimental): 1B8 (Rituximab biosimilar) 375 mg/m2 every 21 days (Intravenous infusions) + CHOP scheme for 6 to 8 cycles.
Group B (Control) MabThera (RITUXAN) 375mg / m2 every 21 days (Intra
Vincristine (1.4 mg/m2 day 1)
Cyclophosphamide (750 mg/m2 day 1)
Prednisolone (100 mg days 1 to 5). It is will administered every 21 days, depending on the patients clinical condition and response to treatment, up to a maximum of 6-8 cycles, considering a maximum c
Rituximab
Antibodies, Monoclonal
Biosimilar Pharmaceuticals
Administration, Intravenous
Doxorubicin
Vincristine
Cyclophosphamide
Prednisone
1B8
RITUXAN
MabThera®
Rituximab biosimilar
CHOP scheme
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients that fulfill diagnosis criteria 2. Eligible for scheme CHOP 3. Age greater than or equal to 18 years and not older than 70 years, of any gender. 4. ECOG performance status less than or equal to 2 5. Express written request of the patient 6. Measurable disease at diagnosis 7. Requirements of the clinical laboratory (Hb= 100 g/L, ALC = 3 x 109 cells/L, ANC = 1,5x109 /L, Platelets =100 x 109/L, Transaminases = 2.5 time upper limit of normal, Creatinine and bilirubin = 1.5 upper limit of normal)
Exclusion criteria
Exclusion criteria: 1. LNH evidence of spread of the central nervous system or primary CNS involvement 2. Extranodal NHL, intravascular or plasmablastic 3. Uncontrolled hypertension 4. History of Demyelinating disease or inflammatory of the CNS or peripheral 5. Pregnancy or breastfeeding. 6. Human Immunodeficiency Virus (HIV) seropositivity 7. History of other cancer, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix. 8. Acute allergy or history of severe allergic reactions or autoimmune disease or primary immunodeficiencies 9. On any other experimental product. 10. History of allergy to active substances, excipients and murine proteins similar to the experimental product or any of the drugs chemotherapy regimen that will receive to the patient 11. Decompensated related chronic disease, they are including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, aortic stenosis, endocarditis and psychiatric diseases that may limit adherence to the requirements of the assay 12. Left Ventricular Ejection Fraction less than 50% 13. Known seropositive for hepatitis B or C virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Pharmacokinetic Serum concentration (Cp). Measurement time: before each cycle of treatment and 3 months after the last cycle Maximum concentration (AUC). Measurement time: before each cycle of treatment and 3 months after the last cycle Half-life (t ½). Measurement time: before each cycle of treatment and 3 months after the last cycle Plasma clearance (CL). Measurement time: before each cycle of treatment and 3 months after the last cycle - Pharmacodynamic - B cells depletion (Absolute counts of CD19+ in peripheral blood). Measurement time: before each cycle of treatment and 3 months after the last cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect: Clinical Response (standardized criteria for NHL: complete remission, unconfirmed complete response, partial remission, stable disease or progressive disease). Measurement time: 4 weeks after the last cycle of treatment Safety: Adverse events (AEs). Measurement time: 10 months - Occurrence of an AE in the subject (yes / no) - Description of AE (Name of adverse event) - Duration of AE (difference between the start dates and completion of the event) - Intensity AE (Mild, Moderate, Severe, Life-threatening or disabling, produces death) - Gravity AE (Severe / serious, severe / not serious) - Attitude to study treatment (unchanged, dose modification, temporary interruption or discontinuation of study treatment) - Result of the AE (recovered, improved, persists or sequels) - Causal relationship (1 Definitive, 2. Very Probable, 3. Probable, 4. Possible 5. Not related 6. Unknown) Immunogenicity: HACA Response (according OD title). Measurement time: before each cycle of treatment, 4 weeks post the last cycle of treatment and 3 months after the last cycle | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinator Center for Clinical Trials
Outcome results
None listed