A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax & Azacitidine in Patients with Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia not Eligible for Intensive Induction Chemo

Clinical Trial Details

This clinical trial is for men and women with Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML).

The purpose of this research is to gather information on the safety and effectiveness of Gilteritinib (sold under the brand name XOSPATA®) in newly diagnosed patients with AML or in combination with azacitidine and venetoclax for treatment of AML.

Gilteritinib (XOSPATA®) is currently approved by the U.S. Food and Drug Administration (FDA) in the United States, Pharmaceutical Medical Devices Agency (PMDA) in Japan and European Medicines Agency (EMA) in Europe, for the treatment of AML in adult patients whose disease has failed prior AML therapies.

In this study, participants will receive a combination of gilteritinib, venetoclax and azacitidine for about 1-4 years, depending on the participants' response to the treatment. Participants may receive follow-up phone conversations every 3 months for 3 years after completing treatment.

Participation is expected to last up to 6 years.

Key Eligibility:

Open to men and women above the age of 18 who have been with Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) not Eligible for Intensive Induction Chemotherapy.
Participants must not have received prior treatment with CAR-T cell therapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Gail J Roboz, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2307026306

ClinicalTrials.gov:

NCT05520567

Status

Open to Enrollment

Age Group

Adult

Disease

Leukemia

Acute Myeloid Leukemia