Clinical trial NCT00308087: Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
Official title: Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, Follicular
Keywords: Sargramostim
Leukine
NHL
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-03-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

The study was terminated early due to low enrollment; significant changes to the protocol would have been required to keep pace with the changing therapeutic landscape of indolent lymphoma.

Eligibility criteria: Inclusion Criteria (abbreviated list):

* Relapsed follicular B-cell lymphoma
* One or more previous therapies for non-Hodgkin's
* At least one measurable tumor by CT scan or MRI
* Additional criteria to be determined at screening visit

Exclusion Criteria (abbreviated list):

* Rituximab refractory (less than 6 months from last treatment with rituximab to relapse)
* Currently receiving treatment for another cancer
* Infection currently being treated
* Active Hepatitis B
* History of HIV infection
* Pregnant
* Additional criteria to be determined at screening visit

Primary outcomes:
measure: Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12
timeFrame: Week 8 (confirmed at Week 12)
Secondary outcomes:
measure: Summary of Treatment-Emergent Adverse Events (TEAE)
timeFrame: up to 12 weeks
measure: Participant Summary of Best Response Across All Visits
timeFrame: up to 24 months
measure: Kaplan-Meier Estimates of Progression-Free Survival
timeFrame: 24 months
measure: Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment
timeFrame: 24 months
measure: Summary of Cost Effectiveness
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Montebello
country: United States
state: California
city: Pleasant Hill
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Elk Grove Village
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Duluth
country: United States
state: Minnesota
city: Fresh Meadows
country: United States
state: New York
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: