Trial Information

A Randomized, Open-Label, Multicenter, Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B Cell Subtype of Diffuse Large B-Cell Lymphoma

This is an open-label (all people know the identity of the intervention), randomized (the
study medication is assigned by chance), active-control (an active substance that is
compared with a study medication to test whether the medication has a real effect in a
clinical study), parallel-group (each group of participants will be treated at the same
time), multicenter (study conducted at multiple sites), and multinational study. The study
consists of 3 phases including: the screening phase (up to 4 weeks before the administration
of study medication); treatment phase (up to 18 weeks); and a posttreatment phase (1 year).
Approximately 164 participants will be randomly assigned to 1 of the 2 treatment arms:
Treatment Arm A (participants will receive 6 cycles of VR-CAP) or Treatment Arm B
(participants will receive 6 cycles of R-CHOP). After 1-year posttreatment phase,
participants will be followed for an additional 1 year for overall survival (the interval
between the date of randomization and the date of death), disease progression, and
subsequent anti-lymphoma therapy. Safety evaluations will include assessment of adverse
events, clinical laboratory tests, vital signs, physical examination, and eastern
cooperative oncology group performance status which will be monitored throughout the study.