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CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality

2014-08-27 03:54:45 | BioPortfolio

Summary

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

PURPOSE: 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.

Description

OBJECTIVES:

Primary

- Determine the efficacy of CC-5013, in terms of hematological improvement, in patients with red blood cell transfusion-dependent low- or intermediate-risk myelodysplastic syndromes and a del(5)(q31q33) cytogenetic abnormality.

Secondary

- Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral CC-5013 on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Myelodysplastic Syndromes

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: 2014-08-27T03:54:45-0400

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PubMed Articles [762 Associated PubMed Articles listed on BioPortfolio]

Relationship between lenalidomide dose modification, duration of therapy, and long-term outcomes in patients with myelodysplastic syndromes.

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Lenalidomide treatment in lower risk myelodysplastic syndromes-The experience of a Czech hematology center. (Positive effect of erythropoietin ± prednisone addition to lenalidomide in refractory or relapsed patients).

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Medical and Biotech [MESH] Definitions

Clonal myeloid disorders that possess both dysplastic and proliferative features but are not properly classified as either MYELODYSPLASTIC SYNDROMES or MYELOPROLIFERATIVE DISORDERS.

These growth factors comprise a family of hematopoietic regulators with biological specificities defined by their ability to support proliferation and differentiation of blood cells of different lineages. ERYTHROPOIETIN and the COLONY-STIMULATING FACTORS belong to this family. Some of these factors have been studied and used in the treatment of chemotherapy-induced neutropenia, myelodysplastic syndromes, and bone marrow failure syndromes.

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