Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Yes
Eric Feldman, M.D.
Principal Investigator
Weill Medical College of Cornell University
United States: Food and Drug Administration
0403-762
NCT00195000
May 2003
February 2008
Name | Location |
---|---|
Weill Medcial College of Cornell University | New York, New York 10021 |