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

Condition(s) targeted: Lymphoma, Follicular

Intervention: Rituximab + Sargramostim (Leukine, BAY86-5326) (Drug); Rituximab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Complete response rate for rituximab plus sargramostim measured at 8 weeks confirmed at 12 weeks

Secondary outcome: Safety, overall response rates, progression free survival, cost effectiveness at 24 months

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

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

Criteria:

Inclusion Criteria:

- 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:

- 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

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

San Juan 00919, Puerto Rico; Recruiting

Anniston, Alabama 36207, United States; Not yet recruiting

Huntsville, Alabama 35805, United States; Recruiting

Birmingham, Alabama 35234, United States; Not yet recruiting

Little Rock, Arkansas 72205, United States; Not yet recruiting

Hot Springs, Arkansas 71913, United States; Not yet recruiting

Loma Linda, California 92354, United States; Not yet recruiting

Montebello, California 90640, United States; Recruiting

Los Angeles, California 90095, United States; Recruiting

Pleasant Hill, California 20037, United States; Recruiting

Los Angeles, California 90089, United States; Not yet recruiting

Washington, District of Columbia 20037, United States; Not yet recruiting

Jacksonville, Florida 32207, United States; Recruiting

Gainesville, Florida 32610-0254, United States; Recruiting

Tampa, Florida 33612, United States; Recruiting

Ocala, Florida 34474, United States; Recruiting

Elk Grove Village, Illinois 60007, United States; Recruiting

Springfield, Illinois 62703, United States; Recruiting

Chicago, Illinois 60612, United States; Not yet recruiting

New Albany, Indiana 47150, United States; Recruiting

Indianapolis, Indiana 46202, United States; Recruiting

Lexington, Kentucky 40503, United States; Not yet recruiting

Duluth, Minnesota 55805-1984, United States; Recruiting

Omaha, Nebraska 68122, United States; Not yet recruiting

Manasquan, New Jersey 08736, United States; Not yet recruiting

New York, New York 10467, United States; Not yet recruiting

Syracuse, New York 13210, United States; Not yet recruiting

New York, New York 10019, United States; Recruiting

Fresh Meadows, New York 11365, United States; Recruiting

Columbus, Ohio 43235, United States; Not yet recruiting

Lawton, Oklahoma 73505, United States; Not yet recruiting

Hershey, Pennsylvania 17033-0850, United States; Recruiting

Philadelphia, Pennsylvania 19104, United States; Not yet recruiting

Johnson City, Tennessee 37604, United States; Not yet recruiting

Houston, Texas 77030, United States; Recruiting

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Starting date: May 2006
Ending date: June 2011
Last updated: January 14, 2009