AMD31003101: Mobilization of Stem Cells With AMD3100 in Non-Hodgkin’s Lymphoma Patients

This study is ongoing, but not recruiting participants.

Sponsored By:	Genzyme AnorMED Corporation, a wholly owned subsidiary of Genzyme
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

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:

Primary Outcomes: Number of CD34+ cells collected by apheresis
Secondary Outcomes: Safety; Engraftment of stem cells; Graft durability

Total Enrollment: 311

Study start: January 2005

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 - 78 Years

Genders Eligible for Study: Both

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

Location Information

Arizona
City of Hope Samaritan Bone Marrow Transplant Program, Phoenix, Arizona, 85006, United States; Recruiting

California
City of Hope National Medical Center, Duarte, California, 91010, United States; Recruiting

Colorado
Rocky Mountain Cancer Center, Denver, Colorado, 80218, United States; Recruiting

Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06520, United States; Recruiting

Florida
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, 33612, United States; Recruiting
Shands Teaching Hospital, University of Florida, Gainesville, Florida, 32610, United States; Recruiting

Illinois
Loyola University Medical Center, Maywood, Illinois, 60153, United States; Recruiting

Indiana
Indiana Blood and Marrow Transplantation Center, Beech Grove, Indiana, 46107, United States; Recruiting

Iowa
University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States; Recruiting

Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Massechusettes General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Beth Israel Deconness Medical Center, Boston, Massachusetts, 02115, United States; Recruiting

Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting
University of Minnesota, Minneapolis, Minnesota, 55455, United States; Recruiting

Missouri
Washington University School of Medicine, St. Louis, Missouri, 63110, United States; Recruiting
Kansas City Cancer Center, Kansas City, Missouri, 64111, United States; Recruiting

Nebraska
Nebraska Medical Center: Clarkson and University Hospitals, Omaha, Nebraska, 68198, United States; Recruiting

New York
University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Roswell Park Cancer Institute, Buffalo, New York, 14263, United States; Recruiting

North Carolina
Duke University Medical Center, Durham, North Carolina, 27705, United States; Recruiting

Ohio
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting
Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting

Oregon
Oregon Health & Science University, Portland, Oregon, 97239, United States; Recruiting

Pennsylvania
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, 19107, United States; Recruiting
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting

Texas
University of Texas Health Science Center, San Antonio, Texas, 78229, United States; Recruiting
Texas Transplant Institute, San Antonio, Texas, 78229, United States; Recruiting
The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Wilford Hall Medical Center, Lackland AFB, Texas, 78236, United States; Recruiting

Virginia
Virginia Commonwealth University, Richmond, Virginia, 23298, United States; Recruiting

Washington
Fred Hutchinson Cancer Research Center, Seattle, Washington, 98109, United States; Recruiting

More Information

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. : 15020611

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. : 12855591

Study ID Numbers: AMD31003101
ClinicalTrials.gov Identifier: NCT00103610
Health Authority: United States: Food and Drug Administration