A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 5 * 10^6 CD34+ Cells/kg in Non-Hodgkin's Lymphoma Patients for Autologous Transplantation
A peripheral stem cell transplant may be able to replace blood-forming cells that were
destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is
used to cause the growth and mobilization of stem cells from bone marrow to peripheral
blood, which can then be collected from the peripheral blood by a process called apheresis.
Plerixafor 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 correlate to faster
recovery times after high dose chemotherapy followed with stem cell transplantation. This
study is intended to determine whether the combination of plerixafor with filgrastim is
better than filgrastim alone in helping non-Hodgkin's lymphoma patients collect at least 5
million stem cells in four or less apheresis sessions.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Days 5 to 8
No
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
AMD3100-3101
NCT00103610
January 2005
December 2007
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Rochester Medical Center | Rochester, New York 14642 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Case Western Reserve University | Cleveland, Ohio 44106 |
University of Texas Health Science Center | San Antonio, Texas 78284 |
Texas Transplant Institute | San Antonio, Texas 78229 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Virginia Commonwealth University | Richmond, Virginia |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
Kansas City Cancer Center | Kansas City, Missouri 64111 |
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
City of Hope Samaritan Bone Marrow Transplant Program | Phoenix, Arizona 85006 |
Shands Teaching Hospital, University of Florida | Gainesville, Florida 32610 |
Indiana Blood and Marrow Transplantation Center | Beech Grove, Indiana 46107 |
Nebraska Medical Center: Clarkson and University Hospitals | Omaha, Nebraska 68198 |