Spots Global Cancer Trial Database for Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality
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Trial Identification
Brief Title: Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality
Official Title: A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.
Study ID: NCT00065156
Conditions
Interventions
Study Description
Brief Summary: This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Scottsdale, Arizona, United States
Mayo Clinic, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
Desert Hematology & Oncology Medical Group, Rancho Mirage, California, United States
Stanford University Medical Center, Stanford, California, United States
Mayo Clinic, Jacksonville, Florida, United States
Cancer & Blood Disease Center, Lecanto, Florida, United States
University of Miami Sylvester Comp Cancer Center, Miami, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Northwest Georgia Oncology - Wellstar Cancer Research, Marietta, Georgia, United States
Rush-Presbyterian- St. Luke's Medical Center, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Midwest Cancer Research Group, Skokie, Illinois, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University School of Medicine, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York Hospital-Cornell, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Mt. Sinai Medical Center, New York, New York, United States
University of Rochester- James P. Wilmot Cancer Center, Rochester, New York, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Kaiser Permanente Northwest Region, Portland, Oregon, United States
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
St. Johannes Hospital, Duisburg, , Germany
Contact Details
Name: Alan F List, MD
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
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