Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

298

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

July 31, 2006

Study Completion Date

December 31, 2007

Conditions
Lymphoma, Non-Hodgkin
Interventions
DRUG

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.

DRUG

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.

Trial Locations (32)

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Rochester

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

23298

Virginia Commonwealth University, Richmond

27705

Duke University Medical Center, Durham

32610

Shands Teaching Hospital, University of Florida, Gainesville

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

44106

Case Western Reserve University, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

46107

Indiana Blood and Marrow Transplantation Center, Beech Grove

52242

University of Iowa Hospitals and Clinics, Iowa City

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

60153

Loyola University Medical Center, Maywood

63110

Washington University School of Medicine, St Louis

64111

Kansas City Cancer Center, Kansas City

68198

Nebraska Medical Center: Clarkson and University Hospitals, Omaha

77030

The University of Texas MD Anderson Cancer Center, Houston

78229

Texas Transplant Institute, San Antonio

University of Texas Health Science Center, San Antonio

78236

Wilford Hall Medical Center, Lackland Air Force Base

80218

Rocky Mountain Cancer Center, Denver

85006

City of Hope Samaritan Bone Marrow Transplant Program, Phoenix

91010

City of Hope National Medical Center, Duarte

97239

Oregon Health & Science University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

06520

Yale University School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

V5Z 1M9

Vancouver General Hospital, Vancouver

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00103610 - Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients | Biotech Hunter | Biotech Hunter