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



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

For Condition: Myelodysplastic Syndrome
Status: No longer recruiting
Sponsor(s): Celgene Corporation ,
Synopsis: 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 .
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 25

Location and Contact Information:

Arizona Cancer Center
Tucson,  Arizona,  85724
United States
 


Additional Information:
Study ID Numbers:
  CC-5013-MDS-501-001; 
Study Start Date: February 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044382

Other Myelodysplastic Syndrome Studies:
1. Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas

2. Study of the Safety and Efficacy of CC-5013 Treatment For Patients with Myelodysplastic Syndrome

3. Leucovorin for the Treatment of 5 q Minus Syndrome

4. The Role of Cyclosporin in Blood Cell Transplants with T-Cell Add-Back for Blood Cancers

5. Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia

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