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NCT00044382 Clinical Trial

Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00044382
Other study ID # CC-5013-MDS-501-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1, 2002
Est. completion date January 30, 2007

Study information
Verified date November 2019
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date January 30, 2007
Est. primary completion date January 1, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CC-5013

Locations
Country Name City State
United States Arizona Cancer Center Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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