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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Eisai Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00882102 |
The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: Decitabine Drug: Gemtuzumab ozogamicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome |
Estimated Enrollment: | 100 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Decitabine + Gemtuzumab Ozogamicin
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Drug: Decitabine
Decitabine 20 mg/m2 IV over 1-1/2 hours daily x 5.
Drug: Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 3 mg/m2 IV on day 5.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gautam Borthakur, M.D. | 713/563-1586 | gborthak@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Gautam Borthakur, M.D. 713-563-1586 gborthak@mdanderson.org | |
Principal Investigator: Gautam Borthakur, M.D. |
Principal Investigator: | Gautam Borthakur, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Gautam Borthakur M.D./ Assistant Professor ) |
Study ID Numbers: | 2008-0288 |
Study First Received: | April 15, 2009 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00882102 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute Myelogenous Leukemia High-Risk Myelodysplastic Syndrome AML MDS Leukemia |
Decitabine Gemtuzumab Ozogamicin Dacogen Mylotarg |
Antimetabolites Immunologic Factors Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Decitabine Leukemia, Myeloid, Acute Gemtuzumab |
Antibodies, Monoclonal Leukemia Preleukemia Acute Myelocytic Leukemia Antibodies Acute Myeloid Leukemia, Adult Bone Marrow Diseases Immunoglobulins |
Antimetabolites Antimetabolites, Antineoplastic Precancerous Conditions Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Antibodies, Monoclonal Leukemia Preleukemia Pathologic Processes Syndrome |
Therapeutic Uses Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Enzyme Inhibitors Leukemia, Myeloid Decitabine Gemtuzumab Pharmacologic Actions Neoplasms Bone Marrow Diseases |