BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT02417129
Phase
PHASE3
Status
Terminated

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    BI 695500 375 mg/M2
  • BI 695500 — DRUG
    BI 695500 375 mg/M2

Study Details

This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.

Key Dates

Start date
Apr 30, 2015
Status verified
Dec 2016
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

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

Arms

  • Experimental: BI 695500
    375 mg/m2; One intravenous infusion once a week for 4 weeks
  • Active Comparator: Rituximab (US reference product)
    375 mg/m2; One intravenous infusion once a week for 4 weeks

Primary Outcome Measure

Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab [ Time Frame: From first administration of study medication until 30 weeks thereafter. ]

Locations (13)

FacilityCityStateZIPSite coordinators
Boehringer Ingelheim Investigational SiteMuscle ShoalsAlabama--
Boehringer Ingelheim Investigational SiteBakersfieldCalifornia--
Boehringer Ingelheim Investigational SiteBurbankCalifornia--
Boehringer Ingelheim Investigational SiteLoma LindaCalifornia--
Boehringer Ingelheim Investigational SiteAlbanyGeorgia--
Boehringer Ingelheim Investigational SiteNorthbrookIllinois--
Boehringer Ingelheim Investigational SitePittsfieldMassachusetts--
Boehringer Ingelheim Investigational SiteMorristownNew Jersey--
Boehringer Ingelheim Investigational SiteEast SetauketNew York--
Boehringer Ingelheim Investigational SiteFayettevilleNorth Carolina--
Boehringer Ingelheim Investigational SiteMiddletownOhio--
Boehringer Ingelheim Investigational SiteCorpus ChristiTexas--
Boehringer Ingelheim Investigational SiteOgdenUtah--

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Boehringer Ingelheim Investigational Site· Muscle Shoals, ALBoehringer Ingelheim Investigational Site· Bakersfield, CABoehringer Ingelheim Investigational Site· Burbank, CABoehringer Ingelheim Investigational Site· Loma Linda, CABoehringer Ingelheim Investigational Site· Albany, GABoehringer Ingelheim Investigational Site· Northbrook, IL

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