Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma, Follicular
- Interventions
- Registration Number
- NCT00308087
- Lead Sponsor
- Genzyme, a Sanofi Company
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab Rituximab - Rituximab + Sargramostim Sargramostim (Leukine) - Rituximab + Sargramostim Rituximab -
- Primary Outcome Measures
Name Time Method Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12 Week 8 (confirmed at Week 12) Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.
- Secondary Outcome Measures
Name Time Method Summary of Treatment-Emergent Adverse Events (TEAE) up to 12 weeks Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.
Participant Summary of Best Response Across All Visits up to 24 months Count of participants' best response within categories defined by the International Working Group (IWG):
\> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease),
\> Complete Response Unconfirmed (unconfirmed complete disappearance),
\> Partial Response (\>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses),
\> Stable Disease (neither response nor disease progression),
\> Progression (new lesion or increase by 50% of previously involved sites from nadir).Kaplan-Meier Estimates of Progression-Free Survival 24 months Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.
Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment 24 months Count of days in which a participant experiences a Partial Response (\>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.
Summary of Cost Effectiveness 24 months A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.