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

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

Detailed Description
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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.

Official Title
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Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-cell Lymphoma

Conditions
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Lymphoma, Follicular

Intervention / Treatment
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* Drug: Sargramostim (Leukine)
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rituximab<br> | Drug: Rituximab<br>* Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks<br>|
| Experimental: Rituximab + Sargramostim<br> | Drug: Sargramostim (Leukine)<br>* Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab<br>* Other names: Bay86-5326;Drug: Rituximab<br>* Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation 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. | Week 8 (confirmed at Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Treatment-Emergent Adverse Events (TEAE) | 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. | up to 12 weeks | 
| Participant Summary of Best Response Across All Visits | 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). | up to 24 months | 
| Kaplan-Meier Estimates of Progression-Free Survival | Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death. | 24 months | 
| Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment | 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. | 24 months | 
| Summary of Cost Effectiveness | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sargramostim, Leukine, NHL