Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
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
1 other identifier
interventional
298
2 countries
32
Brief Summary
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF or generic name 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
Typical duration for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 11, 2005
CompletedFirst Posted
Study publicly available on registry
February 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
September 29, 2010
CompletedMarch 13, 2014
February 1, 2014
1.5 years
February 11, 2005
February 6, 2009
February 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Number of Participants With Adverse Events
up to Day 38
Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis
up to Day 8
Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg
up to Day 8
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Up to Month 13
Median Number of Days to Platelet (PLT) Engraftment
Up to Month 13
- +3 more secondary outcomes
Study Arms (2)
G-CSF plus plerixafor
EXPERIMENTALG-CSF plus placebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Non-Hodgkin's lymphoma in first or second complete or partial remission
- 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
You may not qualify if:
- Failed previous stem cell collection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
City of Hope Samaritan Bone Marrow Transplant Program
Phoenix, Arizona, 85006, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Shands Teaching Hospital, University of Florida
Gainesville, Florida, 32610, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana Blood and Marrow Transplantation Center
Beech Grove, Indiana, 46107, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kansas City Cancer Center
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Medical Center: Clarkson and University Hospitals
Omaha, Nebraska, 68198, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
University of Texas Health Science Center
San Antonio, Texas, 78229, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (1)
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.
PMID: 19720922RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Genzyme MedInfo
- Organization
- Genzyme Corporation
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 11, 2005
First Posted
February 14, 2005
Study Start
January 1, 2005
Primary Completion
July 1, 2006
Study Completion
December 1, 2007
Last Updated
March 13, 2014
Results First Posted
September 29, 2010
Record last verified: 2014-02