Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02947347
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ibrutinib Oral Capsule — DRUG
    Ibrutinib 560mg administered orally daily
  • Placebo — DRUG
    Placebo capsules to match ibrutinib administered orally daily
  • Rituximab — DRUG
    Rituximab 375mg/m\^2 intravenously (IV) weekly

Study Details

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).

Key Dates

Start date
Jan 23, 2017
Status verified
Feb 2026
Primary completion
Feb 21, 2024
Completion
Jun 9, 2025

Study Design

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

Arms

  • Experimental: (Arm A) ibrutinib + rituximab
    Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m\^2 weekly x4 with maintenance.
  • Placebo Comparator: (Arm B) placebo + rituximab
    Participants to receive placebo once daily and rituximab 375mg/m\^2 weekly x4 with maintenance.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by Investigator [ Time Frame: Primary Analysis cut-off; median overall follow-up of 53.75 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
Southern Cancer CenterMobileAlabama36526-
City of HopeDuarteCalifornia91010-
Sansum ClinicSanta BarbaraCalifornia93105-
UCLA Hematology/OncologySanta MonicaCalifornia90095-
Helen F. Graham Cancer Center and Research InstituteNewarkDelaware19713-
SCRI Florida Cancer Specialists SouthFort MyersFlorida33916-
Florida Cancer AffiliatesOcalaFlorida34471-
SCRI Florida Cancer Specialists NorthSt. PetersburgFlorida33709-
Rush University Medical CenterChicagoIllinois60612-
Norton Cancer InstituteLouisvilleKentucky40202-
Goldschmidt Cancer CenterJefferson CityMissouri65109-
Southeast Nebraska Cancer CenterLincolnNebraska68510-
OHSU Knight Cancer Institute Beaverton ClinicBeavertonOregon97006-
Greenville Health SystemGreenvilleSouth Carolina29605-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-1108-
SCRI Tennessee Oncology NashvilleNashvilleTennessee37203-
Texas Oncology (Medical City)DallasTexas75230-
Texas Oncology-Dallas Presbyterian HospitalDallasTexas75231-
SCRI The Center For Cancer and Blood DisordersFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology (Tyler)TylerTexas75702-
Oncology and Hematology Associates of Southwest Virginia (Blacksburg)BlacksburgVirginia24060-
Swedish Cancer InstituteSeattleWashington98104-
Medical Oncology AssociatesSpokaneWashington99208-
W VA University Mary Babb Randolph Cancer CenterMorgantownWest Virginia26506-

Find similar trials in Mobile, AL

By research site
Southern Cancer Center· Mobile, ALCity of Hope· Duarte, CASansum Clinic· Santa Barbara, CAUCLA Hematology/Oncology· Santa Monica, CAHelen F. Graham Cancer Center and Research Institute· Newark, DESCRI Florida Cancer Specialists South· Fort Myers, FL

Related Studies