A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01611090
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Type=exact number, unit=mg, number=420 , form=capsule, route=oral use. Capsule is taken once daily continuously.
  • Bendamustine hydrochloride — DRUG
    Type=exact number, unit=mg, number=70 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Days 2-3 and Cycles 2-6, Days 1-2.
  • Rituximab — DRUG
    Type=exact number, unit=mg, number=375 mg/m2 and 500 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Day 1, and Cycles 2-6, Day 1, respectively.
  • Placebo — DRUG
    Form=capsule, route=oral use. Capsule is taken once daily continuously.

Study Details

The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Key Dates

Start date
Sep 19, 2012
Status verified
Feb 2020
Primary completion
Jan 23, 2019
Completion
Jan 23, 2019

Study Design

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

Arms

  • Experimental: Ibrutinib + BR
    Ibrutinib 420 mg will be administered orally once daily on a continuous schedule. All subjects will receive background therapy with bendamustine and rituximab (BR) for a maximum of 6 cycles (a cycle is defined as 28 days, with the exception of Cycle 1, which will be 29 days to allow for rituximab dosing prior to bendamustine and study medication).
  • Placebo Comparator: Placebo + BR
    Matching placebo will be administered orally once daily on a continuous schedule. All subjects will receive background therapy with BR for a maximum of 6 cycles (a cycle is defined as 28 days, with the exception of Cycle 1, which will be 29 days to allow for rituximab dosing prior to bendamustine and study medication).

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]

Locations (42)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-PhoenixArizona--
-BerkeleyCalifornia--
-DuarteCalifornia--
-GreenbraeCalifornia--
-StamfordConnecticut--
-Washington D.C.District of Columbia--
-Boca RatonFlorida--
-JacksonvilleFlorida--
-AtlantaGeorgia--
-MariettaGeorgia--
-ChicagoIllinois--
-SpringfieldIllinois--
-Fort WayneIndiana--
-GoshenIndiana--
-IndianapolisIndiana--
-Iowa CityIowa--
-WestwoodKansas--
-LouisvilleKentucky--
-PaducahKentucky--
-MarreroLouisiana--
-BaltimoreMaryland--
-WorcesterMassachusetts--
-Ann ArborMichigan--
-Battle CreekMichigan--
-DetroitMichigan--
-LansingMichigan--
-St LouisMissouri--
-LincolnNebraska--
-LebanonNew Hampshire--
-HackensackNew Jersey--
-AlbuquerqueNew Mexico--
-DunkirkNew York--
-HawthorneNew York--
-New YorkNew York--
-BismarckNorth Dakota--
-ClevelandOhio--
-PortlandOregon--
-CharlestonSouth Carolina--
-Sioux FallsSouth Dakota--
-TempleTexas--
-MorgantownWest Virginia--

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