Testing the Combination of Standard Induction Therapy With Gemtuzumab Ozogamicin and Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia

• Status: Suspended
• Trial end date: 2025-01-01

Summary

This phase I study hopes to explore how safe and tolerable is the combination of gemtuzumab ozogamicin (GO) and midostaurin, with the standard induction therapy (cytarabine and daunorubicin) in patients with newly diagnosed FLT-3 mutated Acute Myeloid Leukemia (AML). GO is FDA approved for the treatment of adults with newly diagnosed CD33 positive AML and used in combination with chemotherapy, cytarabine and daunorubicin. Midostaurin is FDA approved for use with cytarabine and daunorubicin in patients with FLT3-mutated AML. By combining standard induction therapy with GO and midostaurin, our aim is to investigate a novel approach to treating patients with newly diagnosed FLT3-mutated AML.

• Phase: Phase 1

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: Fred Hutchinson Cancer Research Center; Oregon Health and Science University; Pfizer
• Treatments: Calicheamicins; Cytarabine; Daunorubicin; Gemtuzumab; Midostaurin; Staurosporine