Gilteritinib + Azacitidine for Acute Myeloid Leukemia

Recruiting at 110 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Must be taking: Azacitidine

Must not be taking: CYP3A inducers, P-gp inhibitors

Disqualifiers: APL, BCR-ABL leukemia, CNS leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

183 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster. For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster. This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

Research Team

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Eligibility Criteria

Adults recently diagnosed with AML and a FLT3 gene mutation, who can't have standard chemo. They must be over 18 (or over 65 in some cases), not suitable for intensive chemotherapy due to age or health issues like heart failure, poor kidney function, or low performance status. Participants need functioning major organs and agree to contraception if of childbearing potential.

Inclusion Criteria

Subject must meet certain clinical laboratory test criteria

I am legally an adult where I live.

My blood or bone marrow tested positive for the FLT3 mutation.

Exclusion Criteria

I need to take certain medications along with my treatment.

Subject with mean Fridericia-corrected QT interval (QTcF) > 480 ms at screening

Subject has specific pulmonary function test results

Treatment Details

Interventions

• Azacitidine
• Gilteritinib

Trial Overview The trial is testing gilteritinib alone or combined with azacitidine versus azacitidine by itself in adults with AML who can't receive standard chemo. Gilteritinib targets the FLT3 protein to slow leukemia growth. Patients are randomly assigned to treatments, with a higher chance of receiving the combination therapy.

Participant Groups

Group I: Dose escalation of ASP2215 given with azacitidine Experimental Treatment 2 Interventions

Subjects will be treated with ASP2215 daily (days 1-28) and azacitidine daily for 7 days (days 1-7).

Group II: Arm AC: ASP2215 + azacitidine Experimental Treatment 2 Interventions

Subjects will be treated with ASP2215 daily and azacitidine daily for 7 days (days 1-7) each 28-day cycle.

Group III: Arm A: ASP2215 Experimental Treatment 1 Intervention

Subjects will be treated daily each 28-day cycle.

Group IV: Arm C: azacitidine Active Control 1 Intervention

Subjects will be treated with azacitidine for 7 days (days 1-7) each 28-day cycle.

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Vidaza for:

• Acute myeloid leukemia
• Chronic myelomonocytic leukemia
• Myelodysplastic syndromes

Approved in United States as Vidaza for:

• Myelodysplastic syndromes
• Chronic myelomonocytic leukemia

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available