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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


N/A
N/A
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Autologous Transplantation

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Trial Information

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).


Inclusion Criteria:



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

Exclusion Criteria:

- No Exclusion Criteria

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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).

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD31003101LTF

NCT ID:

NCT00741325

Start Date:

June 2006

Completion Date:

November 2011

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Autologous Transplantation
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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