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Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)

Overall Recruitment Status: Enrollment on hold

Official Title

Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML)

Region

Sponsors

California - Northern

PrECOG, LLC.

Acronym

NCT No.

NCT03836209

Study Type

Phase

INTERVENTIONAL

Phase II

Purpose

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML.

Detailed Description

Inclusion Criteria

Any patient undergoing bone marrow biopsy with suspicion of or known diagnosis of acute myeloid leukemia (AML) will be asked to sign a Prescreening Consent to allow for centralized testing of bone marrow/peripheral blood samples.

Exclusion Criteria

Patient with malignancy that could interfere with the evaluation of safety or efficacy of this combination. Patient with a history of Long QT Syndrome. Patient with evidence of uncontrolled angina Patient who has undergone major surgery or radiation therapy within 4 weeks of registration

Keywords and/or Specific Medical Conditions

Hematology

Oncology (Adult)

KP Clinical Facility

Diablo Medical Center-Walnut Creek
Oakland Medical Center-Alameda
Roseville Medical Center
Sacramento Medical Center
San Francisco Medical Center
San Leandro Medical Center
Santa Clara Medical Center-Homestead
South Sacramento Medical Center
Vallejo Medical Center