drugset / Trial / NCT00499343

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

NCT00499343

Phase 2 Completed 84 enrolled M.D. Anderson Cancer Center Bayer · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject G-CSF Unknown 6 ug/kg Subcutaneous
Subject Rituximab Monoclonal antibody 1000 mg/m2 Intravenous
Subject sargramostim Protein / enzyme biologic 250 ug/m2
Background Etoposide Small molecule 150 mg/m2 Intravenous
Background Ifosfamide Small molecule 10 g Intravenous

Indications