CompletedPhase 3

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

United States371 participantsStarted 2015-10-20

Plain-language summary

The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and determined 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 also determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participant must have achieved a CR/CRi/CRp (criteria as defined by \[Cheson et al, 2003\], see Section 5.3) with first line treatment and has hematologic relapse.
✓. post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
✓. documented as surgically sterile (at least 1 month prior to Screening)
✓. Agree not to try to become pregnant during the study and for 180 days after the final study administration
✓. And have a negative urine pregnancy test at Screening
✓. And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at Screening and throughout the study period and for 180 days after the final study drug administration.

What they're measuring

Duration of Overall Survival (OS)

Timeframe: From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months)

Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm

Timeframe: From the date of randomization up to at least 112 days

Trial details

NCT IDNCT02421939

SponsorAstellas Pharma Global Development, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-17

Results submitted2019-09-12

View on ClinicalTrials.gov More Leukemia, Acute Myeloid (AML) trials