Gilteritinib for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+126 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Astellas Pharma Global Development, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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.

+6 more

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.

+13 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: GilteritinibExperimental Treatment1 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 ChemotherapyActive Control4 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.