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GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma

NCT00896519 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-02

No results posted yet for this study

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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make more blood cells and help it recover from the side effects of rituximab and combination chemotherapy.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and combination chemotherapy works in treating patients with previously untreated advanced follicular non-Hodgkin lymphoma.

Conditions

Interventions

BIOLOGICAL

rituximab

BIOLOGICAL

sargramostim

DRUG

cyclophosphamide

DRUG

doxorubicin hydrochloride

DRUG

prednisone

DRUG

vincristine sulfate

GENETIC

gene expression analysis

GENETIC

gene rearrangement analysis

GENETIC

polymerase chain reaction

OTHER

R-CHOP regimen

OTHER

laboratory biomarker analysis

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Jean-Francois Rossi, MD, PhD · Hopital Lapeyronie-CHU Montpellier

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-03-31

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Entities

Drugs
Diseases

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 NCT00896519 on ClinicalTrials.gov