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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00384956 |
The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes |
Drug: intravenous azacitidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes |
Estimated Enrollment: | 21 |
Study Start Date: | August 2006 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Initially all patients will be given azacitidine 75 mg/m2 intravenously on days 1-5 of a 28 day cycle.
Patients that do not respond to therapy after two cycles will have the dose increased to 100 mg/m2.
Primary Objective To estimate the rate of complete remission (CR) and partial remission (PR) after four cycles of therapy in patients with high risk myelodysplastic syndrome (MDS).
Secondary Objectives
The secondary objectives of the study are:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
MDS either de novo or secondary, fitting any of the WHO classifications[44, 45]. Patients with 5% bone marrow blasts must also meet one of the following criteria:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Ravi Vij, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Ravi Vij, M.D. ) |
Study ID Numbers: | 06-0585 |
Study First Received: | October 4, 2006 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00384956 History of Changes |
Health Authority: | United States: Institutional Review Board |
MDS either de novo or secondary, fitting any of the WHO classifications. |
Antimetabolites Preleukemia Precancerous Conditions Hematologic Diseases |
Myelodysplastic Syndromes Azacitidine Neoplasm Metastasis Bone Marrow Diseases |
Antimetabolites Disease Antimetabolites, Antineoplastic Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Enzyme Inhibitors |
Pharmacologic Actions Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Azacitidine Bone Marrow Diseases |