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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00741325
First received: August 22, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 Intervention
Non-Hodgkin's Lymphoma
Autologous Transplantation
Drug: granulocyte colony-stimulating factor (G-CSF)
Drug: plerixafor
Drug: Placebo

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 178
Study Start Date: June 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from the AMD3100-3101 study (NCT00103610) who received at least one dose of study treatment (plerixafor or placebo)

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741325

Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00741325     History of Changes
Other Study ID Numbers: AMD31003101LTF
Study First Received: August 22, 2008
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014