Status:
COMPLETED
Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplas...
Detailed Description
To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years. Patients eli...
Eligibility Criteria
Inclusion
- Histologic diagnosis of AML or advanced MDS
- No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C).
Exclusion
- Uncontrolled or severe cardiovascular disease or pulmonary disease
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00195000
Start Date
May 1 2003
End Date
February 1 2008
Last Update
June 19 2013
Active Locations (1)
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1
Weill Medcial College of Cornell University
New York, New York, United States, 10021