Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Molgramostim

Sargramostim

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab

Sargramostim (Leukine)

Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks

Medical Monitor

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

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.

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

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

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.

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.

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).

Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.

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.

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.

Genzyme, a Sanofi Company

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.

Rituximab + Sargramostim

Total

Age, Continuous

Sex: Female, Male

Caucasian

Black

Hispanic

Asian

Other

Race/Ethnicity, Customized

One hundred ninety-six patients were planned and 75 enrolled prior to termination. The study was terminated early due to low enrollment, and the extent of changes needed to the protocol to keep pace with therapeutic changes for indolent lymphoma.

Genzyme MedInfo

Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12

Patients with TEAEs

Patients with Treatment-Related TEAEs

Number of Deaths

Patients with Serious TEAEs

Patients with Study Discontinuation due to TEAEs

Summary of Treatment-Emergent Adverse Events (TEAE)

Complete Response

Complete Response Unconfirmed

Partial Response

Stable Disease

Progression

Unknown

Participant Summary of Best Response Across All Visits

Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.

Kaplan-Meier Estimates of Progression-Free Survival

Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment

No participants were analyzed because the study was terminated early due to low enrollment.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial