Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma

Part of paid clinical trials in Burbank, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT01980654
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    All subjects will receive 560 mg of Ibrutinib orally.
  • rituximab — DRUG
    All subjects will receive rituximab 375 mg/m2 intravenously

Study Details

This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).

Key Dates

Start date
Dec 31, 2013
Status verified
Mar 2019
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017

Study Design

Enrollment
80 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Main Study Arm 1
    Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.
  • Experimental: Exploratory Study Arm 2
    Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR) [ Time Frame: Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks. ]

Locations (12)

FacilityCityStateZIPSite coordinators
Providence Saint Joseph Medical CenterBurbankCalifornia91505-
City of HopeDuarteCalifornia91010-
UCLA Medical CenterLos AngelesCalifornia90095-
Stanford University, Stanford Care CenterStanfordCalifornia94305-
Southeastern Regional Medical CenterNewnanGeorgia30265-
Community Health Network Community Regional Cancer Center NorthIndianapolisIndiana46256-
Comprehensive Cancer Centers of NevadaHendersonNevada89074-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical College New York-Presbyterian HospitalNew YorkNew York10065-
Mid-Ohio Oncology/ Hematology IncColumbusOhio43219-
Tennessee Oncology, PLLC The Sarah Cannon Research InstituteNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Burbank, CA

By research site
Providence Saint Joseph Medical Center· Burbank, CACity of Hope· Duarte, CAUCLA Medical Center· Los Angeles, CAStanford University, Stanford Care Center· Stanford, CASoutheastern Regional Medical Center· Newnan, GACommunity Health Network Community Regional Cancer Center North· Indianapolis, IN

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