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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074126 |
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.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes |
Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Red Blood Cell Transfusion-Dependent Subjects With Myelodysplastic Syndromes Associated With a DEL (5q) Cytogenetic Abnormality |
Study Start Date: | July 2003 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a del(5)(q31q33) cytogenetic abnormality
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
If marrow aspirate not evaluable for storage iron, the following criteria must be met:
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Stephen D. Nimer, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000343384, MSKCC-03085, CELGENE-CC-5013-MDS-003 |
Study First Received: | December 10, 2003 |
Last Updated: | August 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00074126 History of Changes |
Health Authority: | United States: Federal Government |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Lenalidomide |
Chromosome Aberrations Neoplasm Metastasis Bone Marrow Diseases Congenital Abnormalities |
Disease Precancerous Conditions Hematologic Diseases Antineoplastic Agents Myelodysplastic Syndromes Lenalidomide Pharmacologic Actions |
Preleukemia Neoplasms Pathologic Processes Syndrome Therapeutic Uses Chromosome Aberrations Bone Marrow Diseases |