At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
In Brief
A Phase 2 clinical trial evaluating Etoposide, G-CSF, and 4 other interventions for Lymphoma. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
150 mg/m\^2 given intravenously over 2 hours every 12 hours x 6 doses.
Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
250 mcg/m\^2 injection given every evening till the completion of apheresis.
10 g/m\^2 given intravenously continuous infusion over 72 hours.
Days +1 (375 mg/m\^2) and +8 (1000 mg/m\^2) given intravenously.
Peripheral blood stem cell collection.