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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants who will Achieve Complete Response (CR)
CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms present before therapy. It will be evaluated by computed tomography (CT) scan and positron emission tomography (PET) scan with supportive clinical evidences. CT scan and PET scan will be done at the end of Cycles 3 and 6.
From the date of randomization until progressive disease or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the randomization of the last participant
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
United States: Food and Drug Administration