A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Global rank composite score (GRCS) at 54 months post- randomization.
The GRCS reflects each participant's "order" relative to every other participant based on the following hierarchy of component outcomes: death, event-free survival (EFS), forced vital capacity (FVC), Modified Scleroderma Health Questionnaire (SHAQ), and modified Rodnan Skin Score (mRSS).The analysis for the global rank composite score is based on an extension of the Wilcoxon signed-rank test.
At 54 Months Post-Randomization
Yes
Keith Sullivan, MD
Study Chair
Division of Cellular Therapy, Duke University
United States: Food and Drug Administration
DAIT SCSSc-01
NCT00114530
June 2005
June 2016
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Boston University School of Medicine | Boston, Massachusetts 02118 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Duke University | Durham, North Carolina 27710 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
UCLA Medical School | Los Angeles, California 90095-1670 |
University of Toledo Health Science Campus | Toledo, Ohio 43699 |
University of Texas-Houston Medical School | Houston, Texas 77030 |
Fred Hutchinson Cancer Research Center (FHCRC) | Seattle, Washington 98109 |