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Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma

NCT00411086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-05

Study results available
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Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma.

PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.

Conditions

Interventions

BIOLOGICAL

Rituximab

375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22.

BIOLOGICAL

Sargramostim (GM-CSF)

250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nathan Fowler, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00411086 on ClinicalTrials.gov