A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01855750
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    560 mg capsules administered by mouth once daily (21-day cycles)
  • Placebo — DRUG
    4 matched capsules administered by mouth once daily (21-day cycles)
  • Rituximab — DRUG
    375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Cyclophosphamide — DRUG
    750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Doxorubicin — DRUG
    50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Vincristine — DRUG
    1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
  • Prednisone (or equivalent) — DRUG
    100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

Study Details

The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

Key Dates

Start date
Sep 3, 2013
Status verified
Jan 2025
Primary completion
Feb 26, 2018
Completion
Apr 5, 2019

Study Design

Enrollment
838 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Treatment Arm A: placebo + R-CHOP
    Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)
  • Experimental: Treatment Arm B: ibrutinib + R-CHOP
    Treatment Arm B = ibrutinib + R-CHOP

Primary Outcome Measure

Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population [ Time Frame: Up to 5.5 years ]

Locations (44)

FacilityCityStateZIPSite coordinators
-TucsonArizona--
-GreenbraeCalifornia--
-La JollaCalifornia--
-Los AngelesCalifornia--
-SalinasCalifornia--
-StanfordCalifornia--
-DanburyConnecticut--
-HartfordConnecticut--
-Washington D.C.District of Columbia--
-AtlantaGeorgia--
-MariettaGeorgia--
-PeoriaIllinois--
-Fort WayneIndiana--
-GoshenIndiana--
-IndianapolisIndiana--
-TopekaKansas--
-LouisvilleKentucky--
-Baton RougeLouisiana--
-New OrleansLouisiana--
-BaltimoreMaryland--
-BethesdaMaryland--
-BostonMassachusetts--
-Ann ArborMichigan--
-St LouisMissouri--
-OmahaNebraska--
-HackensackNew Jersey--
-New BrunswickNew Jersey--
-Fresh MeadowsNew York--
-Johnson CityNew York--
-MineolaNew York--
-New YorkNew York--
-RochesterNew York--
-The BronxNew York--
-CharlotteNorth Carolina--
-GreenvilleNorth Carolina--
-HickoryNorth Carolina--
-ColumbusOhio--
-PortlandOregon--
-North CharlestonSouth Carolina--
-NashvilleTennessee--
-HoustonTexas--
-TempleTexas--
-BurlingtonVermont--
-SeattleWashington--

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