IRB #

STUDY00018684

Title

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)

Principal Investigator

Uma Borate

Study Purpose

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.

Medical Condition(s)

Acute Myeloid Leukemia (AML) - newly diagnosed

Eligibility Criteria

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

Age Range

18 - 99

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

OHSU - Investigator Initiated Trial funded by Pfizer Pharmaceuticals, Inc

Recruitment End

01/01/2030

Compensation Provided

No


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