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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT03900949
Run by: Uma Borate
People needed: 21
Starts: 2019-03-13
Expected to finish: 2025-10-23
Last updated by the study team: 2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to understand and the willingness to sign a written informed consent document
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Newly diagnosed AML as confirmed by bone marrow and/or peripheral blood examination as indicated, with:
Confirmed CD33 positivity, per institutional standards
Presence of FLT3 internal tandem duplication (ITD) or tyrosine kinase domain (TKD) mutation as confirmed by next-generation sequencing (NGS) or other molecular method
Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN; local laboratory)
Alanine aminotransferase (ALT) < 2.5 x ULN
Total bilirubin < 2 x ULN (except for patients with known Gilbert's syndrome)
Calculated creatinine clearance (according to the Cockcroft-Gault equation) > 40 mL/min OR serum creatinine < 1.5 x the ULN
Female patients of childbearing potential must agree to use adequate contraception (2 forms of contraception or abstinence) from the screening visit until 6 months following the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from the screening visit until 4 months following the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 4 months following the last dose of study treatment

You may not qualify if…

Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement to enter study)
Acute promyelocytic leukemia (per World Health Organization classification)
Active central nervous system (CNS) involvement by AML, as assessed at discretion of principal investigator (PI) or treating physician and confirmed by lumbar puncture
Except for hydroxyurea, no other prior systemic anti-AML therapies may have been received prior to starting study therapy
Known history of veno-occlusive disease
Known active human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C infection
Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled ventricular arrhythmias
Patients with uncontrolled infection will not be enrolled until infection is treated
Any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
Inability to take oral medication
Hypersensitivity to any study agent, or its excipients, when administered alone
Pregnancy or breastfeeding at the time of enrollment

Where it is running

Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
Oregon Health and Science University Knight Cancer Institute - Northwest Portland — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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