PCI-32765DBL3001: 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

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PCI-32765DBL3001: 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

The primary objective is to evaluate if the addition of ibrutinib to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) prolongs event-free survival (EFS) compared with R-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.

The secondary objectives are to:
Evaluate PFS
Evaluate overall survival
Evaluate CR rate
Evaluate patient-reported lymphoma symptoms and concerns as measured by the Lym
subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

Evaluate the treatment benefit of ibrutinib in subjects with the ABC subtype based on GEP

Characterize the pharmacokinetics of ibrutinib and to explore the potential relationships between ibrutinib metrics of exposure with relevant clinical or biomarker information

Evaluate the safety of ibrutinib when combined with R-CHOP

Protocol Number011304
Principal InvestigatorKevin David
PhasePhase III
ScopeNational
Applicable Disease SitesNon-Hodgkin's Lymphoma
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedIBRUTINIB
VINCRISTINE
CYCLOPHOSPHAMIDE
PREDNISONE
RITUXIMAB
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.