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

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00741325
Collaborator
(none)
178
Enrollment
65
Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: granulocyte colony-stimulating factor (G-CSF)
  • Drug: plerixafor
  • Drug: Placebo

Detailed 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).

Study Design

Study Type:
Observational
Actual Enrollment :
178 participants
Time Perspective:
Prospective
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 :
Jun 1, 2006
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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)

Drug: plerixafor
Other Names:
  • Mozobil
  • AMD3100

    		•
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients who received a dose of study treatment (plerixafor or placebo)in protocol AMD3100-3101 (NCT00103610)
    Exclusion Criteria:
    • No Exclusion Criteria

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Medical Monitor, Genzyme, a Sanofi Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00741325
    Other Study ID Numbers:
    • AMD31003101LTF
    First Posted:
    Aug 26, 2008
    Last Update Posted:
    Feb 11, 2014
    Last Verified:
    Feb 1, 2014
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Plerixafor
    Lenograstim

    Study Results

    No Results Posted as of Feb 11, 2014