A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01776840
Phase
PHASE3
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6
  • Rituximab — DRUG
    375 mg/m2 administered intravenously on Day 1, Cycles 1-6; if complete response or partial response is achieved, 375 mg/m2 is administered on Day 1 of every second cycle for a maximum of 12 additional doses
  • Ibrutinib — DRUG
    560 mg (4 x 140 mg capsules) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end
  • Placebo — DRUG
    4 capsules administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or the final analysis of progression-free survival

Study Details

The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

Key Dates

Start date
May 16, 2013
Status verified
Jun 2025
Primary completion
Jun 30, 2021
Completion
Jun 24, 2024

Study Design

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

Arms

  • Placebo Comparator: Treatment Arm A
  • Experimental: Treatment Arm B

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 97 months ]

Locations (44)

FacilityCityStateZIPSite coordinators
-TucsonArizona--
-BurbankCalifornia--
-La JollaCalifornia--
-StanfordCalifornia--
-DenverColorado--
-New HavenConnecticut--
-StamfordConnecticut--
-ChicagoIllinois--
-MaywoodIllinois--
-NilesIllinois--
-SpringfieldIllinois--
-GoshenIndiana--
-Iowa CityIowa--
-Sioux CityIowa--
-TopekaKansas--
-WestwoodKansas--
-LexingtonKentucky--
-LouisvilleKentucky--
-MetairieLouisiana--
-Ann ArborMichigan--
-DetroitMichigan--
-Jefferson CityMissouri--
-LincolnNebraska--
-HackensackNew Jersey--
-New BrunswickNew Jersey--
-AlbuquerqueNew Mexico--
-AlbanyNew York--
-HawthorneNew York--
-New YorkNew York--
-DurhamNorth Carolina--
-GreenvilleNorth Carolina--
-BismarckNorth Dakota--
-FargoNorth Dakota--
-EugeneOregon--
-PortlandOregon--
-PhiladelphiaPennsylvania--
-GreenvilleSouth Carolina--
-WatertownSouth Dakota--
-NashvilleTennessee--
-HoustonTexas--
-San AntonioTexas--
-BurlingtonVermont--
-SpokaneWashington--
-VancouverWashington--

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