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RATIONALE: CC-5013 may stop the growth of myelodysplastic syndrome by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who have transfusion-dependent low-risk or intermediate-risk myelodysplastic syndrome.
- Determine the efficacy of CC-5013, in terms of hematopoietic improvement, in patients with transfusion-dependent low- or intermediate-1-risk myelodysplastic syndromes.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral CC-5013 once daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 136 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:37-0400
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A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.
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