Comparative,Randomized,Double Blind Study to Evaluate Biologic Effect and Safety of PBO-326 (Rituximab), Associated to CHOP-14 Compared With Mabthera (Rituximab) Associated to CHOP-14 in B Cells CD20+ Diffuse Non-Hodgkin Lymphoma Patients
At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone)
has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.
Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel
Rituximab in comparison with Mabthera and evaluates safety both metabolic as well
Study protocolo is designed to provide data on impact of treatment interchange of both study
drugs (PBO-326 and Mabthera).
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Basal and final serum CD 20 levels comparison.
Primary outcome is the depletion of CD20+ B cells. This will be measured every 14 days and comparison will be made basal levels versus visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and visit 8.
Every 14 days for the duration of treatment
Jorge Revilla Beltri, MD
Probiomed S.A. de C.V.
Mexico: Federal Commission for Protection Against Health Risks