A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01974440
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.
  • Rituximab — DRUG
    375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.
  • Cyclophosphamide — DRUG
    750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.
  • Doxorubicin — DRUG
    50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.
  • Vincristine — DRUG
    1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.
  • Prednisone — DRUG
    100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.
  • PCI-32765 (Ibrutinib) — DRUG
    560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.
  • Placebo — DRUG
    Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.

Study Details

The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.

Key Dates

Start date
Jan 31, 2014
Status verified
May 2025
Primary completion
May 30, 2022
Completion
Jun 21, 2023

Study Design

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

Arms

  • Placebo Comparator: Treatment Arm A
    Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab \[BR\] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]) for 6 cycles + placebo.
  • Experimental: Treatment Arm B
    Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).

Primary Outcome Measure

Primary Analysis: Progression Free Survival (PFS): Stratified Analysis [ Time Frame: Up to 8 years ]

Locations (32)

FacilityCityStateZIPSite coordinators
-GilbertArizona--
-CampbellCalifornia--
-DuarteCalifornia--
-La JollaCalifornia--
-Los AngelesCalifornia--
-OrangeCalifornia--
-OcalaFlorida--
-ChicagoIllinois--
-MaywoodIllinois--
-IndianapolisIndiana--
-WestwoodKansas--
-LexingtonKentucky--
-LafayetteLouisiana--
-ScarboroughMaine--
-BaltimoreMaryland--
-BethesdaMaryland--
-BostonMassachusetts--
-Ann ArborMichigan--
-Battle CreekMichigan--
-DetroitMichigan--
-Saint Louis ParkMinnesota--
-DenvilleNew Jersey--
-New YorkNew York--
-HickoryNorth Carolina--
-PinehurstNorth Carolina--
-BendOregon--
-PittsburghPennsylvania--
-Sioux FallsSouth Dakota--
-HoustonTexas--
-LubbockTexas--
-SpokaneWashington--
-Green BayWisconsin--

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