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Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia

NCT00940342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2018-09-19

Study results available
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Summary

The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.

Conditions

Interventions

DRUG

GM-CSF (Sargramostim)

250 mcg injection under the skin, three times a week for eight weeks.

DRUG

Rituximab

375 mg/m\^2 administered intravenously once weekly for four weeks

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Alessandra Ferrajoli, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-12
Primary Completion
2017-01-05
Completion
2017-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00940342 on ClinicalTrials.gov