Long-Term Follow-up Study for Non-Hodgkin's Lymphoma Patients Who Received Autologous Transplantation in the AMD3100-3101 Study - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00741325

Purpose

This is a long-term observational study of transplanted patients that participated in the AMD3100-3101 protocol

Condition
Non-Hodgkin's Lymphoma Autologous Transplantation

MedlinePlus related topics: Lymphoma

Drug Information available for: Granulocyte colony-stimulating factor JM 3100

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by Genzyme:

Primary Outcome Measures:

To assess disease-free survival and overall survival in transplanted patients from the phase III AMD3100-3101 study [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2010

Detailed Description:

This is a long-term observational study of transplanted patients that have completed a multicenter, randomized, double blind, placebo-controlled investigational study to evaluate G-CSF plus AMD3100 versus G-CSF plus placebo to mobilize and transplant Non-Hodgkin's Lymphoma (NHL)patients (protocol) AMD3100-3101). The objective of this study is to assess disease-free survival and overall survival for a period of three years following the initial 12-month post-transplantation follow-up of the investigational study.

Eligibility

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

Study Population

Patients from the AMD3100-3101 who received a stem cell transplant

Criteria

Inclusion Criteria:

All patients who received a stem cell transplant in protocol AMD3100-3101

Exclusion Criteria:

No Exclusion Criteria

Contacts and Locations

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

Sponsors and Collaborators

Genzyme

Investigators

Study Director:	Frank Hsu, MD	Genzyme
Principal Investigator:	Patrick Stiff, MD	Loyola University

More Information

Responsible Party:	Genzyme Corporation ( Frank Hsu, MD )
Study ID Numbers:	AMD3100-3101-LTF
Study First Received:	August 22, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741325
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
JM 3100
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009