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G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

NCT00499343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2013-08-02

Study results available
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Summary

Primary Objectives:

1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups.

Secondary Objectives:

1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging.
2. To determine the incidence of disease progression/relapse at 12 months in the two groups.

Conditions

Interventions

DRUG

Etoposide

150 mg/m\^2 given intravenously over 2 hours every 12 hours x 6 doses.

DRUG

G-CSF

Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.

DRUG

GM-CSF

250 mcg/m\^2 injection given every evening till the completion of apheresis.

DRUG

Isophosphamide

10 g/m\^2 given intravenously continuous infusion over 72 hours.

DRUG

Rituximab

Days +1 (375 mg/m\^2) and +8 (1000 mg/m\^2) given intravenously.

PROCEDURE

Apheresis

Peripheral blood stem cell collection.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Chitra M. Hosing, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-10-31
Completion
2008-10-31

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 NCT00499343 on ClinicalTrials.gov