Gilteritinib for Acute Myeloid Leukemia

Recruiting at 126 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

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

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: 1

Duration: Variable (up to 885 days for ASP2215, up to 217 days for salvage chemotherapy)

371 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

Who Is on the Research Team?

Executive Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with relapsed or refractory Acute Myeloid Leukemia (AML) that have a specific mutation called FLT3. They should not have had success with first-line AML therapy and must be physically able to handle the treatments, as indicated by an ECOG performance status of 2 or less. Women of childbearing age must agree to use effective contraception and not breastfeed.

Inclusion Criteria

I am eligible for a specific follow-up chemotherapy.

Participant must meet specific clinical laboratory test criteria

I have been diagnosed with acute myeloid leukemia, either primary or following MDS.

Exclusion Criteria

Participant has clinically significant abnormality of coagulation profile

Participant has any condition which makes the Participant unsuitable for study participation

I have active leukemia in my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive ASP2215 or salvage chemotherapy in continuous 28-day cycles

Variable (up to 885 days for ASP2215, up to 217 days for salvage chemotherapy)

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation

30 days

1 visit (telephone contact)

Long-term Follow-up

Long-term follow-up every 3 months up to 3 years from the participant's end-of-treatment visit

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• ASP2215
• Azacitidine
• FLAG-IDA
• gilteritinib
• LoDAC
• MEC

Trial Overview The study tests ASP2215 against standard salvage chemotherapy in patients whose AML has returned after treatment or didn't respond to initial therapy. It aims to see if ASP2215 can improve overall survival, event-free survival, and rates of complete remission compared to existing chemotherapy options.

How Is the Trial Designed?

Group I: Gilteritinib Experimental Treatment 1 Intervention

Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria.

Group II: Salvage Chemotherapy Active Control 4 Interventions

Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15.

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