A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With 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 a randomized (individuals assigned to study treatment by chance), double-blind
(individuals and study personnel will not know the identity of study treatments), placebo
(an inactive substance that is compared with a drug to test whether the drug has a real
effect in a clinical trial)-controlled study to compare the efficacy and safety of ibrutinib
in combination with R-CHOP versus R-CHOP alone in adult patients newly diagnosed non-GCB
DLBCL. The study will include screening, active treatment, and posttreatment follow-up
phases. The study will end when 50% of participants have died or the sponsor terminates the
study, whichever occurs first (up to approximately 7 years). Approximately 800 participants
will be randomly assigned in a 1:1 ratio to receive either placebo+R-CHOP (treatment arm A)
or ibrutinib+R-CHOP (treatment arm B). All participants will receive R-CHOP as background
therapy for 6 or 8 cycles (21 days per cycle) according to site preference. After 4
treatment cycles, an interim response assessment will be performed to evaluate disease
progression. Participants with progressive disease or relapsed disease after complete
response will be discontinued from treatment. Participants who discontinue R-CHOP without
disease progression will continue study drug (placebo or ibrutinib) until 6 or 8 cycles are
completed, disease progression, or unacceptable toxicity, whichever occurs first. After
completion of study drug, participants will undergo assessment of tumor response based on
the Revised Response Criteria for Malignant Lymphoma. Participants with documented residual
disease upon completion of at least 6 cycles of R-CHOP therapy are considered eligible to
initiate subsequent antilymphoma therapy. Serial pharmacokinetic samples will be collected
before and after dosing, and safety will be monitored throughout the study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Event-free survival
Up to disease progression, relapse from complete response, initiation of subsequent systemic antilymphoma therapy after completion of at least 6 cycles of R-CHOP therapy, or death, whichever occurs first, up to Year 7
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Czech Republic: State Institute for Drug Control
CR102118
NCT01855750
August 2013
June 2020
Name | Location |
---|---|
Fountain Valley, California 92708 | |
Albany, New York 12208 | |
Seattle, Washington 98195 | |
Omaha, Nebraska 68114 | |
Indianapolis, Indiana |