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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: | NCT00077506 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
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 RBC Transfusion-Dependent Subjects With Myelodysplastic Syndromes |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of low- or intermediate-1-risk myelodysplastic syndromes (MDS)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
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 |
Study Chair: | Virginia Klimek, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000352173, MSKCC-03109, CELGENE-CC-5013-MDS-002 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077506 |
Health Authority: | United States: Federal Government |
chronic myelomonocytic leukemia previously treated myelodysplastic syndromes de novo myelodysplastic syndromes |
myelodysplastic/myeloproliferative disease, unclassifiable secondary myelodysplastic syndromes atypical chronic myeloid leukemia |
Myelodysplastic syndromes Chronic myelogenous leukemia Precancerous Conditions Chronic myelomonocytic leukemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplasia Myelodysplastic Syndromes Lenalidomide |
Myeloproliferative Disorders Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Syndrome Pharmacologic Actions |