Trial Information
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
CC-5013-MDS-501-001
NCT ID:
NCT00044382
Start Date:
February 2002
Completion Date:
Related Keywords:
- Myelodysplastic Syndrome
- Revimid
- CC5013
- CC-5013
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
Arizona Cancer Center |
Tucson, Arizona 85724 |