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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Eisai Inc. |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00882102 |
Purpose
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, high-risk MDS or MF. The safety of this drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: Decitabine Drug: Gemtuzumab ozogamicin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Decitabine + Gemtuzumab Ozogamicin |
Drug: Decitabine
Decitabine 20 mg/m2 IV over 1-1/2 hours daily x 5.
Other Name: Dacogen®
Drug: Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 3 mg/m2 IV on day 5.
Other Name: Mylotarg®
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Gautam Borthakur, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00882102 History of Changes |
| Other Study ID Numbers: | 2008-0288 |
| Study First Received: | April 15, 2009 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Acute Myelogenous Leukemia High-Risk Myelodysplastic Syndrome AML MDS Leukemia |
Decitabine Gemtuzumab Ozogamicin Dacogen Mylotarg |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Decitabine Gemtuzumab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |