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

Myelodysplastic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099267
• Other study ID #: CC-5013-MDS-009
• Secondary ID: CC-5013-MDS-003E
• Status: Completed
• Start date: March 1, 2010
• Est. completion date: October 1, 2010

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 1, 2010
• Est. primary completion date: October 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

Locations

Country	Name	City	State
Germany	St. Johannes Hospital	Duisburg
United States	John Hopkins University Hospital	Baltimore	Maryland
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	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cancer & Blood Disease Center	Lecanto	Florida
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Mayo Clinic - Scottsdale	Scottsdale	Arizona
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford University Cancer Center	Stanford	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (2)

Göhring G, Giagounidis A, Büsche G, Hofmann W, Kreipe HH, Fenaux P, Hellström-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. — View 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 syndr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Survival Status as of the Time of the Extension Study Follow-up	Count of participants who were alive or deceased at the time of the extension study follow-up.	up to 7 years
Primary	Kaplan Meier Estimate for Overall Survival	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.	up to 7 years
Primary	Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up	Count of participants who progressed to AML at the time of the extension study follow-up.	up to 7 years
Primary	Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)	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.	up to 7 years
Primary	Cause of Death for Participants Who Died	Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.	up to 7 years