Active — Not RecruitingPhase 3

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

China276 participantsStarted 2017-10-25

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 AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as 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

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must have achieved a CR/CRi/CRp with first-line treatment and has hematologic relapse.

What they're measuring

Overall Survival (OS)

Timeframe: From the date of randomization up to the date of death (up to approximatley 74 months)

Trial details

NCT IDNCT03182244

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-25

Results submitted2024-11-06

View on ClinicalTrials.gov More AML With FLT3 Mutation trials