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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Follicular

Intervention: Sargramostim (Leukine) (Drug); Rituximab (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Summary of Treatment-Emergent Adverse Events (TEAE)

Participant Summary of Best Response Across All Visits

Kaplan-Meier Estimates of Progression-Free Survival

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

Summary of Cost Effectiveness

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

San Juan 00919, Puerto Rico

Birmingham, Alabama 35234, United States

Huntsville, Alabama 35805, United States

Los Angeles, California 90095, United States

Montebello, California 90640, United States

Pleasant Hill, California 94523, United States

Gainesville, Florida 32610-0254, United States

Jacksonville, Florida 32207, United States

Ocala, Florida 34474, United States

Tampa, Florida 33612, United States

Chicago, Illinois 60612, United States

Elk Grove Village, Illinois 60007, United States

Springfield, Illinois 62703, United States

Indianapolis, Indiana 46202, United States

New Albany, Indiana 47150, United States

Duluth, Minnesota 55805-1984, United States

Fresh Meadows, New York 11365, United States

New York, New York 10019, United States

Columbus, Ohio 43235, United States

Hershey, Pennsylvania 17033-0850, United States

Philadelphia, Pennsylvania 19104, United States

Houston, Texas 77030, United States

Additional Information

Starting date: May 2006
Last updated: December 2, 2013

Page last updated: August 23, 2015

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