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

This study is currently recruiting participants.

Verified by Bayer, April 2009

First Received: March 28, 2006 Last Updated: April 20, 2009 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00308087

Purpose

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

Condition	Intervention	Phase
Lymphoma, Follicular	Drug: Rituximab + Sargramostim (Leukine, BAY86-5326) Drug: Rituximab	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Open Label, Phase II Trial Comparing Rituximab Plus Sargramostim to Rituximab Monotherapy for the Treatment of Relapsed Follicular B-Cell Lymphoma

Further study details as provided by Bayer:

Primary Outcome Measures:

Complete response rate for rituximab plus sargramostim measured at 8 weeks confirmed at 12 weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, overall response rates, progression free survival, cost effectiveness at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	196
Study Start Date:	May 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rituximab + Sargramostim (Leukine, BAY86-5326) Rituximab for 4 weeks with sargramostim three times/week for 8 weeks
Arm 2: Active Comparator	Drug: Rituximab Rituximab alone weekly for 4 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308087

Contacts

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Show 36 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91499, 310421, PREMIER
Study First Received:	March 28, 2006
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00308087 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Bayer:

Sargramostim
Leukine
NHL

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Follicular
Follicular Lymphoma
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse

Lymphatic Diseases
B-cell Lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lymphoma, Follicular
Pharmacologic Actions

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 06, 2009