drugset / Trial / NCT00499343
G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |