Spots Global Cancer Trial Database for A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
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Trial Identification
Brief Title: A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
Official Title: A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies
Study ID: NCT01696461
Interventions
Study Description
Brief Summary: This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.
Detailed Description: The primary objective is to determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections. All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.Recipients will be classified into one of the two strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Duke University, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
West Virginia University, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Steve Devine, MD
Affiliation: NMDP/BeTheMatch
Role: PRINCIPAL_INVESTIGATOR
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