|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968071 |
Purpose
The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) 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 |
|---|---|---|
|
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: | A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS) |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Decitabine + Gemtuzumab Ozogamicin |
Drug: Decitabine
20 mg/m^2 IV over an hour and half daily x 5 days.
Other Name: Dacogen
Drug: Gemtuzumab Ozogamicin
3 mg/m^2 IV on day 5.
Other Names:
|
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 | |
| Study Chair: | Gautam Borthakur, MBBS | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968071 History of Changes |
| Other Study ID Numbers: | 2007-0882 |
| Study First Received: | August 26, 2009 |
| Last Updated: | October 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Leukemia AML MDS High-Risk Myelodysplastic Syndrome Decitabine |
5-aza-2 deoxycytidine Dacogen Gemtuzumab Ozogamicin 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 |