Clinical trial NCT01099267: Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
Official title: Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: MDS
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2010-04-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects Previously Enrolled in Celgene Protocol NCT00065156 (CC-5013-MDS-003)

Brief summary: Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).


Eligibility criteria: Inclusion Criteria:

1. Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
2. Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data).

Exclusion Criteria:

1. Consent refused for any reason at current or long-term follow up completed in 2007 (long-term follow up: survival data collection completed to obtain further safety information on CC-5013-MDS-003 discontinued subjects from May - October 2007).

Primary outcomes:
measure: Participants Survival Status as of the Time of the Extension Study Follow-up
timeFrame: up to 7 years
measure: Kaplan Meier Estimate for Overall Survival
timeFrame: up to 7 years
measure: Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
timeFrame: up to 7 years
measure: Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)
timeFrame: up to 7 years
measure: Cause of Death for Participants Who Died
timeFrame: up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Stanford
country: United States
facility: Stanford University Cancer Center
state: California
city: Lecanto
country: United States
facility: Cancer & Blood Disease Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins University Hospital
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Duisburg
country: Germany
facility: St. Johannes Hospital
Study officials:
affiliation: Celgene Corporation
name: Barry Skikne, MD
role: STUDY_DIRECTOR
References:
citation: Gohring G, Giagounidis A, Busche G, Hofmann W, Kreipe HH, Fenaux P, Hellstrom-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.
citation: List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65. doi: 10.1056/NEJMoa061292.