Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

Completed

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT01099267
• Lead Sponsor: Celgene

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-01
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Primary Completion: 2010-10-01
• Study Completion: 2010-10-01
• Results First Submitted: 2011-10-05
• Results First Submitted QC: 2011-10-05
• Results First Posted: 2011-11-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants Survival Status as of the Time of the Extension Study Follow-up	up to 7 years	Count of participants who were alive or deceased at the time of the extension study follow-up.
Cause of Death for Participants Who Died	up to 7 years	Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.
Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up	up to 7 years	Count of participants who progressed to AML at the time of the extension study follow-up.
Kaplan Meier Estimate for Overall Survival	up to 7 years	Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.
Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)	up to 7 years	Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.

Trial Locations

Locations (15)

Stanford University Cancer Center; 🇺🇸 Stanford, California, United States

Cancer & Blood Disease Center; 🇺🇸 Lecanto, Florida, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Northwest Georgia Oncology Centers, P.C.; 🇺🇸 Marietta, Georgia, United States

Hematology Oncology Associates of Illinois; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

John Hopkins University Hospital; 🇺🇸 Baltimore, Maryland, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

St. Johannes Hospital; 🇩🇪 Duisburg, Germany

Mayo Clinic - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States