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
immunologic.
Study protocolo is designed to provide data on impact of treatment interchange of both study
drugs (PBO-326 and Mabthera).
Interventional
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
No
Jorge Revilla Beltri, MD
Study Director
Probiomed S.A. de C.V.
Mexico: Federal Commission for Protection Against Health Risks
PRO-1908
NCT01277172
October 2010
October 2011
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