Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
NCT ID: NCT00103610
Last Updated: 2014-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
298 participants
INTERVENTIONAL
2005-01-31
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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G-CSF plus plerixafor
Granulocyte colony-stimulating factor plus plerixafor
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
G-CSF plus placebo
Granulocyte colony-stimulating factor plus placebo
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Interventions
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Granulocyte colony-stimulating factor plus plerixafor
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Granulocyte colony-stimulating factor plus placebo
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* White Blood Cell count (WBC) \> 2.5\*10\^9/L
* Platelet (PLT) \> 100\*10\^9/L
Exclusion Criteria
* Prior autologous or allogeneic transplant
* Brain metastases or bone marrow involvement \> 20%
* Radiation to pelvis
* Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
18 Years
78 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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City of Hope Samaritan Bone Marrow Transplant Program
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Shands Teaching Hospital, University of Florida
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation Center
Beech Grove, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Cancer Center
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Medical Center: Clarkson and University Hospitals
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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References
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DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.
Related Links
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Further information on non-Hodgkin's lymphoma from the National Cancer Institute
Other Identifiers
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AMD3100-3101
Identifier Type: -
Identifier Source: org_study_id
NCT00248508
Identifier Type: -
Identifier Source: nct_alias
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