Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genzyme, a Sanofi Company
Study ID
NCT00308087
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

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

Interventions

  • Sargramostim (Leukine) — DRUG
    Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab
  • Rituximab — DRUG
    Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks

Study Details

The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.

Key Dates

Start date
May 31, 2006
Status verified
Dec 2013
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009

Study Design

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

Arms

  • Active Comparator: Rituximab
  • Experimental: Rituximab + Sargramostim

Primary Outcome Measure

Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12 [ Time Frame: Week 8 (confirmed at Week 12) ]

Locations (21)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35234-
-HuntsvilleAlabama35805-
-Los AngelesCalifornia90095-
-MontebelloCalifornia90640-
-Pleasant HillCalifornia94523-
-GainesvilleFlorida32610-0254-
-JacksonvilleFlorida32207-
-OcalaFlorida34474-
-TampaFlorida33612-
-ChicagoIllinois60612-
-Elk Grove VillageIllinois60007-
-SpringfieldIllinois62703-
-IndianapolisIndiana46202-
-New AlbanyIndiana47150-
-DuluthMinnesota55805-1984-
-Fresh MeadowsNew York11365-
-New YorkNew York10019-
-ColumbusOhio43235-
-HersheyPennsylvania17033-0850-
-PhiladelphiaPennsylvania19104-
-HoustonTexas77030-

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