Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3101 Study (NCT00103610).
|ClinicalTrials.gov Identifier: NCT00741325|
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : February 11, 2014
|Condition or disease||Intervention/treatment|
|Non-Hodgkin's Lymphoma Autologous Transplantation||Drug: granulocyte colony-stimulating factor (G-CSF) Drug: plerixafor Drug: Placebo|
|Study Type :||Observational|
|Actual Enrollment :||178 participants|
|Official Title:||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|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
G-CSF plus plerixafor
Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received plerixafor, prior to undergoing apheresis.
Drug: granulocyte colony-stimulating factor (G-CSF)
G-CSF plus placebo
Participants in Study AMD3100-3101 (NCT00103610)underwent mobilization with granulocyte colony-stimulating factor (G-CSF)and received placebo, prior to undergoing apheresis.
|Drug: granulocyte colony-stimulating factor (G-CSF) Drug: Placebo|
- 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). [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741325
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|