Phase I Study to Evaluate the Safety and Tolerability of Gemtuzumab Ozogamicin (Mylotarg) in Combination with Cytarabine, Anthracycline and Midostaurin Induction for Patients with Newly Diagnosed FLT3 Positive Acute Myeloid Leukemia (AML)
This study is being done to answer the following question:
How safe and tolerable is the combination of gemtuzumab ozogamicin (GO - study drug) and midostaurin with the standard induction chemotherapy (cytarabine and daunorubicin) in patients with newly diagnosed FLT-3 mutated AML
Gemtuzumab oxogamicin (GO) is approved by the Food and Drug Administration (FDA) for the treatment of adults with newly diagnosed CD33-positive AML, and is used in conjunction with the usual approach (7+3 cytarabine and daunorubicin chemotherapy
We are doing this study because we want to find out if the addition of the study drug to the usual approach for treating AML is better or worse than the usual approach alone.
Acute Myeloid Leukemia (AML) - newly diagnosed
Eligible subjects must meet the following:
-Be 18 years of age or older
-Newly diagnosed acute myeloid leukemia as confirmed by bone marrow biopsy
-Presence of FLT3 ITD or TKD mutation as confirmed by NGS
18 - 99
Healthy Volunteers Needed
Duration of Participation
The study drug will be given for as long as it is tolerated and the disease is not getting worse. Side effects will be monitored for 30 days after end of treatment. Patients will be followed every 3 months for a period of 2 years afterwards.
Clinical Trials Information Line
OHSU - Investigator Initiated Trial funded by Pfizer Pharmaceuticals, Inc