Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 5X 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation
This is a long-term observational study of patients who received at least one dose of study
treatment (plerixafor or placebo) in a multicenter, randomized, double blind,
placebo-controlled investigational study to evaluate granulocyte colony stimulating factor
(G-CSF) plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's
Lymphoma (NHL) patients (protocol AMD3100-3101 [NCT00103610]). The objective of this study
is to assess progression-free survival and overall survival of patients treated with at
least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following
the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101
(NCT00103610).
Observational
Time Perspective: Prospective
Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3101 (NCT00103610).
5 years
No
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
AMD31003101LTF
NCT00741325
June 2006
November 2011
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