Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01099267
First received: April 5, 2010
Last updated: November 30, 2011
Last verified: November 2011
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Purpose
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
| Condition |
|---|
|
Myelodysplastic Syndrome |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003 |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Participants Survival Status as of the Time of the Extension Study Follow-up [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]Count of participants who were alive or deceased at the time of the extension study follow-up.
- Kaplan Meier Estimate for Overall Survival [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]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.
- Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]Count of participants who progressed to AML at the time of the extension study follow-up.
- Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML) [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]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.
- Cause of Death for Participants Who Died [ Time Frame: up to 7 years ] [ Designated as safety issue: Yes ]Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.
| Enrollment: | 54 |
| Study Start Date: | March 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Lenalidomide
No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects Previously Enrolled in Celgene Protocol NCT00065156 (CC-5013-MDS-003)
Criteria
Inclusion Criteria:
- Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099267
Locations
| United States, Arizona | |
| Mayo Clinic - Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Stanford University Cancer Center | |
| Stanford, California, United States, 94305 | |
| United States, Florida | |
| Cancer & Blood Disease Center | |
| Lecanto, Florida, United States, 34461 | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Northwest Georgia Oncology Centers, P.C. | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Hematology Oncology Associates of Illinois | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| John Hopkins University Hospital | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Minnesota | |
| Mayo Clinic - Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, North Carolina | |
| Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Germany | |
| St. Johannes Hospital | |
| Duisburg, Germany, D-47166 | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Barry Skikne, MD | Celgene Corporation |
More Information
No publications provided by Celgene Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01099267 History of Changes |
| Other Study ID Numbers: | CC-5013-MDS-009, CC-5013-MDS-003E |
| Study First Received: | April 5, 2010 |
| Results First Received: | October 5, 2011 |
| Last Updated: | November 30, 2011 |
| Health Authority: | United States: Institutional Review Board Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Celgene Corporation:
|
MDS |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Neoplasms Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012
