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Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia
Sponsor: Uma Borate
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.
Official title: A Phase I Study to Evaluate the Safety and Tolerability of Gemtuzumab Ozogamicin and Midostaurin When Used in Combination With Standard Cytarabine and Daunorubicin Induction for Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2019-03-13
Completion Date
2025-10-23
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic SCT
Cytarabine
Given IV
Daunorubicin Hydrochloride
Given IV
Gemtuzumab Ozogamicin
Given IV
Midostaurin
Given PO
Locations (2)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health and Science University Knight Cancer Institute - Northwest Portland
Portland, Oregon, United States