Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma

Part of paid clinical trials in Long Beach, California.

Sponsor
Gilead Sciences
Study ID
NCT02258529
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Idelalisib — DRUG
    150 tablets administered orally twice daily
  • Rituximab — BIOLOGICAL
    375 mg/m\^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)

Study Details

The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Key Dates

Start date
Sep 14, 2015
Status verified
Apr 2017
Primary completion
Apr 12, 2016
Completion
May 3, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Idelalisib + rituximab
    Idelalisib + rituximab for up to 104 weeks

Primary Outcome Measure

Overall Response Rate

Locations (6)

FacilityCityStateZIPSite coordinators
Pacific Shores Medical GroupLong BeachCalifornia90813-
Florida Cancer SpecialistsFort MyersFlorida33916-
St. Agnes HospitalBaltimoreMaryland21229-
Prarie Lakes Health Care Systems, Inc.WatertownSouth Dakota57201-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Northwest Medical Specialties, PLLCTacomaWashington98405-

Find similar trials in Long Beach, CA

By research site
Pacific Shores Medical Group· Long Beach, CAFlorida Cancer Specialists· Fort Myers, FLSt. Agnes Hospital· Baltimore, MDPrarie Lakes Health Care Systems, Inc.· Watertown, SDTennessee Oncology, PLLC· Nashville, TNNorthwest Medical Specialties, PLLC· Tacoma, WA

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