Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Gilead Sciences
Study ID
NCT01569295
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Idelalisib — DRUG
    Idelalisib 150 mg administered orally twice daily
  • Rituximab — DRUG
    Rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a maximum of 6 infusions
  • Bendamustine — DRUG
    Bendamustine 70 mg/mg\^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
  • Placebo to match idelalisib — DRUG
    Placebo to match idelalisib administered orally twice daily

Study Details

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

Key Dates

Start date
Jun 15, 2012
Status verified
Mar 2020
Primary completion
Jun 10, 2019
Completion
Jun 10, 2019

Study Design

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

Arms

  • Experimental: Idelalisib+bendamustine+rituximab
    Participants will receive idelalisib plus bendamustine and rituximab
  • Placebo Comparator: Placebo to match idelalisib+bendamustine+rituximab
    Participants will receive placebo to match idelalisib plus bendamustine and rituximab

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 84 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805-
UCLA Medical CenterLos AngelesCalifornia90095-
Stanford Cancer CenterPalo AltoCalifornia94035-
Rocky Mountain Cancer CenterDenverColorado80218-
University of FloridaGainesvilleFlorida32603-
Winship Cancer Institute at Emory UniversityAtlantaGeorgia30322-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of Nebraska Medical CenterOmahaNebraska68198-
Summit Medical Group, P.A.MorristownNew Jersey07962-
North Shore University HospitalManhassetNew York11030-
Long Island Jewish Medical CenterNew Hyde ParkNew York11042-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Willamette Valley Cancer CenterEugeneOregon97477-
Charleston Hematology OncologyCharlestonSouth Carolina29414-
Texas OncologyAustinTexas78731-
Texas Oncology PADallasTexas75246-
Texas OncologyFort WorthTexas76104-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Seattle Cancer Care AllianceSeattleWashington98109-
Cancer Care Northwest, US OncologySpokaneWashington99202-
Virginia Cancer Specialists, PCVancouverWashington98684-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Huntsville, AL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Clearview Cancer Institute· Huntsville, ALUCLA Medical Center· Los Angeles, CAStanford Cancer Center· Palo Alto, CARocky Mountain Cancer Center· Denver, COUniversity of Florida· Gainesville, FLWinship Cancer Institute at Emory University· Atlanta, GA

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