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Study 14 of 594 for search of: | received on or after 01/16/2009 |
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Sponsors and Collaborators: |
Duke University Celgene Corporation |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00828802 |
The purpose of this study is to find out what dose of lenalidomide is safe to use in combination with decitabine when given in people with myelodysplastic syndrome.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes |
Drug: Lenalidomide, Decitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of Lenalidomide in Combination With Decitabine for Patients With High Grade Myelodysplastic Syndromes |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 1: Experimental
Lenalidomide (5mg) and Decitabine
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Drug: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
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Cohort 2: Experimental
Lenalidomide (10 mg) and Decitabine
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Drug: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
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Cohort 3: Experimental
Lenalidomide (15 mg) and Decitabine
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Drug: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
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Cohort 4: Experimental
Lenalidomide (20 mg) and Decitabine
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Drug: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
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Cohort 5: Experimental
Lenalidomide (25 mg) and Decitabine
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Drug: Lenalidomide, Decitabine
Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
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Myelodysplastic syndrome (MDS) is a group of different kinds of stem cell abnormalities. It is characterized by low blood counts and abnormal blood cell formation. These abnormal blood cells can cause fatigue, shortness of breath, infection, and bleeding. There is significant risk of developing acute leukemia in this disorder.
The only known curative therapy is an allogeneic bone marrow transplant of which the vast majority of patients with this disorder are not candidates. Currently three drugs have been approved for the treatment of MDS: azacytidine, decitabine and lenalidomide for low grade patients with a chromosome 5q abnormality. Azacytidine and decitabine have been demonstrated to improve blood counts, improve the quality of life, and decrease the risk of progression to AML or death in a sizable minority of MDS patients. A recent study of MDS patients who had responded clinically to decitabine revealed that their bone marrow biopsies still showed stromal abnormalities such as increased angiogenesis. Lenalidomide acts at the level of the stromal - marrow cell interaction. It is hypothesized that the combination of decitabine with lenalidomide may show synergistic results.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Carlos de Castro, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Carlos de Castro, MD/Principal investigator ) |
Study ID Numbers: | 00010179 |
Study First Received: | January 22, 2009 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00828802 |
Health Authority: | United States: Institutional Review Board |
Myelodysplastic Syndromes MDS |
Myelodysplastic syndromes Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplasia |
Myelodysplastic Syndromes Lenalidomide Decitabine Bone Marrow Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |