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CC-5013 in Treating Patients With Transfusion-Dependent Low-Risk or Intermediate-Risk Myelodysplastic Syndrome

2014-08-27 03:54:37 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- Determine the efficacy of CC-5013, in terms of hematopoietic improvement, in patients with transfusion-dependent low- or intermediate-1-risk myelodysplastic syndromes.

Secondary

- 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

lenalidomide

Location

Memorial Sloan-Kettering Cancer Center
New York
New York
United States
10021

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:37-0400

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Medical and Biotech [MESH] Definitions

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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A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) arising during the propagation of S37 mouse sarcoma, and causing lymphoid leukemia in mice. It also infects rats and newborn hamsters. It is apparently transmitted to embryos in utero and to newborns through mother's milk.

A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

A lymphoid leukemia characterized by a profound LYMPHOCYTOSIS with or without LYMPHADENOPATHY, hepatosplenomegaly, frequently rapid progression, and short survival. It was formerly called T-cell chronic lymphocytic leukemia.

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