Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Phase 2
Completed
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndrome
- Registration Number
- NCT00195000
- Lead Sponsor
- Weill Medical College of Cornell University
- 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 Myelodysplastic Syndrome over the age of 60 years.
- 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 eligible for treatment will receive the following:
Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion
Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- 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).
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Exclusion Criteria
- Uncontrolled or severe cardiovascular disease or pulmonary disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years. From entry until 30 days post treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Weill Medcial College of Cornell University
🇺🇸New York, New York, United States