Back to resultsStudy of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Primary Purpose
Myelodysplastic Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CC-5013
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Revimid, CC5013, CC-5013
Eligibility Criteria
Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration. Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline. More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion. Women must not be pregnant or lactating No use of another experimental study drug within 30 dy\ays of baseline Understand and sign written informed consent Able to adhere to study visit schedule, understand and comply with other protocol requirements.
Sites / Locations
- Arizona Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044382
Brief Title
Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Official Title
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2002 (Actual)
Primary Completion Date
January 1, 2007 (Actual)
Study Completion Date
January 30, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Revimid, CC5013, CC-5013
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CC-5013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
Women must not be pregnant or lactating
No use of another experimental study drug within 30 dy\ays of baseline
Understand and sign written informed consent
Able to adhere to study visit schedule, understand and comply with other protocol requirements.
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15703420
Citation
List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.
Results Reference
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Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
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