A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01599949
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Type=exact number, unit=mg, number=560, form=capsule, route=oral use. 560 mg oral ibrutinib is to be administered once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

Key Dates

Start date
Aug 31, 2012
Status verified
May 2016
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
120 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib

Primary Outcome Measure

Overall response rate [ Time Frame: 1 year after the last patient is enrolled ]

Locations (32)

FacilityCityStateZIPSite coordinators
-La JollaCalifornia--
-Los AngelesCalifornia--
-StanfordCalifornia--
-NorwalkConnecticut--
-JacksonvilleFlorida--
-ChicagoIllinois--
-PeoriaIllinois--
-GoshenIndiana--
-Iowa CityIowa--
-Sioux CityIowa--
-WestwoodKansas--
-LexingtonKentucky--
-LouisvilleKentucky--
-MetairieLouisiana--
-BaltimoreMaryland--
-BostonMassachusetts--
-WorcesterMassachusetts--
-Ann ArborMichigan--
-DetroitMichigan--
-Jefferson CityMissouri--
-St LouisMissouri--
-OmahaNebraska--
-HackensackNew Jersey--
-New YorkNew York--
-SyracuseNew York--
-WatertownSouth Dakota--
-NashvilleTennessee--
-HoustonTexas--
-BurlingtonVermont--
-CharlottesvilleVirginia--
-MorgantownWest Virginia--
-MadisonWisconsin--

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