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NCT00741325 Clinical Trial

Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3101 Study (NCT00103610).

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00741325
Other study ID # AMD31003101LTF
Secondary ID
Status Completed
Phase N/A
First received August 22, 2008
Last updated February 10, 2014
Start date June 2006
Est. completion date November 2011

Study information
Verified date February 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3101 protocol (NCT00103610).

Description:

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).

Recruitment information / eligibility
Status Completed
Enrollment 178
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients who received a dose of study treatment (plerixafor or placebo)in protocol AMD3100-3101 (NCT00103610)

Exclusion Criteria:

- No Exclusion Criteria

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• granulocyte colony-stimulating factor (G-CSF)

• plerixafor

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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