Mobilization of Stem Cells With AMD3100 in Non-Hodgkin's Lymphoma Patients - Full Text View

Sponsors and Collaborators:	Genzyme AnorMED
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00103610

Purpose

The purpose of this study is to determine whether the combination of AMD3100 and G-CSF (filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma patients for autologous transplantation.

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin	Drug: AMD3100 Drug: filgrastim Procedure: Autologous hematopoietic stem cell transplantation Procedure: Autologous peripheral blood stem cell transplantation Procedure: Hematopoietic stem cell mobilization Procedure: Leukapheresis	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Filgrastim JM 3100

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect > 5 x 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation

Further study details as provided by Genzyme:

Primary Outcome Measures:

Number of CD34+ cells collected by apheresis

Secondary Outcome Measures:

Safety
Engraftment of stem cells
Graft durability

Enrollment:	311
Study Start Date:	January 2005
Study Completion Date:	December 2007

Detailed Description:

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim, a colony stimulating factor, is used to cause the growth of stem cells, which can then be collected from the peripheral blood by a process called apheresis.

AMD3100 aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation are correlated to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of AMD3100 with filgrastim is better than filgrastim alone in helping non-Hodgkin's lymphoma patients collect more than 5 million stem cells in four or less apheresis sessions.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (Abbreviated List):

Non-Hodgkin's lymphoma in first or second complete or partial remission
ECOG performance status of 0 or 1
White Blood Cell count (WBC) > 2.5 x 10^9/L
Platelet (PLT) > 100 x 10^9/L

Exclusion Criteria (Abbreviated List):

Failed previous stem cell collection
Prior autologous or allogeneic transplant
Brain metastases or bone marrow involvement > 20%
Radiation to pelvis
History of ventricular arrhythmias

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103610

Show 31 Study Locations

Sponsors and Collaborators

Genzyme

AnorMED

More Information

Additional Information:

Further information on non-Hodgkin's lymphoma from the National Cancer Institute This link exits the ClinicalTrials.gov site

Publications:

Devine SM, Flomenberg N, Vesole DH, Liesveld J, Weisdorf D, Badel K, Calandra G, DiPersio JF. Rapid mobilization of CD34+ cells following administration of the CXCR4 antagonist AMD3100 to patients with multiple myeloma and non-Hodgkin's lymphoma. J Clin Oncol. 2004 Mar 15;22(6):1095-102.

Liles WC, Broxmeyer HE, Rodger E, Wood B, Hubel K, Cooper S, Hangoc G, Bridger GJ, Henson GW, Calandra G, Dale DC. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood. 2003 Oct 15;102(8):2728-30. Epub 2003 Jul 10.

Study ID Numbers:	AMD3100-3101
Study First Received:	February 11, 2005
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00103610 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Non-Hodgkin's lymphoma
Stem cell mobilization

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Anti-HIV Agents
Immunoproliferative Disorders
Anti-Retroviral Agents

JM 3100
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antiviral Agents
Lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Anti-HIV Agents
Immune System Diseases
JM 3100
Antiviral Agents
Pharmacologic Actions

Lymphatic Diseases
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009