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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of CC-5013 in Patients With Red Blood Cell Transfusion-Dependent Low- or Intermediate-Risk Myelodysplastic Syndromes and a del(5)(q31q33) Cytogenetic Abnormality

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Pharmaceutical / Industry	MSKCC-03085 CELGENE-CC-5013-MDS-003, NCT00074126

Trial Description

Purpose:

CC-5013 may slow the progression of myelodysplasia and allow the body to produce normal red blood cells.

Phase II trial to study the effectiveness of CC-5013 in treating patients who require red blood cell transfusions for anemia caused by myelodysplastic syndrome associated with a cytogenetic abnormality.

Eligibility:

• At least 18 years old
• Received at least two red blood cell transfusions within the past 8 weeks
• No previous CC-5013
• More than 4 weeks since chemotherapy for myelodysplastic syndrome
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive CC-5013 by mouth once a day for 3 weeks. Treatment may be repeated every 4 weeks for up to six courses.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Stephen Nimer, MD, Principal investigator		Ph: 212-639-7871; 800-525-2225

Registry Information
Official Title		A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects with Myelodysplastic Syndromes Associated with a DEL (5q) Cytogenetic Abnormality
Trial Start Date		2003-07-22
Trial Completion Date		2009-05-12
Registered in ClinicalTrials.gov		NCT00074126
Date Submitted to PDQ		2003-10-22
Information Last Verified		2009-08-05
NCI Grant/Contract Number		CA08748

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