PCI-32765MCL3002: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

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PCI-32765MCL3002: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Primary objective: To evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of PFS in subjects with newly diagnosed MCL who are 65 years of age or older

Secondary Objectives:
- To evaluate overall survival
- To evaluate the CR rate and overall response rate (CR+PR)
- To evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
- To evaluate the minimal residual disease (MRD) negative rate
- To evaluate duration of response
- To evaluate time-to-next treatment (TTNT)
- To evaluate the safety of ibrutinib when combined with BR
- To characterize the pharmacokinetics of ibrutinib and explore the potential relationships between ibrutinib metrics of exposure with relevant clinical, pharmacodynamic, or biomarker information

Protocol Number021305
Principal InvestigatorKevin David
PhasePhase III
ScopeNational
Applicable Disease SitesNon-Hodgkin's Lymphoma
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedRITUXIMAB
BENDAMUSTINE
PLACEBO
IBRUTINIB
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.