Study 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.

Additional Study Details

Phase
Phase 3
Product
  • Gilteritinib
  • Cytarabine
  • Mitoxantrone
  • Etoposide
  • G-CSF
  • Fludarabine
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    276
    Show Additional Study Details

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

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      Locations

      Contact Us
      Contact Us
      Completed
      Site RU501
      Saint Petersburg, Russian Federation
      Completed
      Site SG403
      Singapore, Singapore
      Completed
      Site CN113
      Zhengzhou, China
      Completed
      Site CN126
      Shanghai, China
      Completed
      Site CN133
      Lanzhou, China
      Completed
      Site MY301
      Johor Bahru, Malaysia
      Completed
      Site CN108
      Beijing, China
      Completed
      Site CN122
      Xi'an, China
      Completed
      Site CN117
      Jinan, China
      Active, not recruiting
      Site CN119
      Fuzhou, China
      Completed
      Site MY305
      George Town, Malaysia
      Completed
      Site TH202
      Khon Kaen, Thailand
      Completed
      Site CN128
      Nanjing, China
      Completed
      Site MY304
      Kota Kinabalu, Malaysia
      Completed
      Site CN105
      Wuhan, China
      Completed
      Site TH204
      Chiang Mai, Thailand
      Completed
      Site CN120
      Changsha, China
      Withdrawn
      Site RU503
      Tula, Russian Federation
      Completed
      Site CN102
      Guangzhou, China
      Withdrawn
      Site CN112
      Beijing, China
      Completed
      Site RU506
      Kemerovo, Russian Federation
      Completed
      Site CN110
      Beijing, China
      Completed
      Site CN101
      Tianjin, China
      Completed
      Site MY306
      Ampang, Malaysia
      Completed
      Site SG401
      Singapore, Singapore
      Completed
      Site RU507
      Saint Petersburg, Russian Federation
      Completed
      Site CN109
      Beijing, China
      Completed
      Site RU502
      Saint-Petersburg, Russian Federation
      Completed
      Site TH205
      Bangkok, Thailand
      Completed
      Site RU508
      Moscow, Russian Federation
      Completed
      Site MY302
      Kuala Lumpur, Malaysia
      Completed
      Site TH201
      Khon Kaen, Thailand
      Completed
      Site SG402
      Singapore, Singapore
      Completed
      Site TH203
      Bangkok, Thailand
      Completed
      Site CN129
      Shanghai, China
      Completed
      Site CN136
      Zhengzhou, China
      Active, not recruiting
      Site CN121
      Guangzhou, China
      Completed
      Site MY303
      Pulau Pinang, Malaysia
      Completed
      Site RU504
      Krasnoyarsk, Russian Federation
      Completed
      Site CN125
      Shenyang, China
      Completed
      Site RU509
      Moscow, Russian Federation
      Completed
      Site CN131
      Beijing, China
      Completed
      Site CN132
      Zhangzhou, China
      Completed
      Site CN106
      Qingdao, China
      Completed
      Site CN130
      Guiyang City, China
      Completed
      Site CN116
      Changchun, China
      Completed
      Site CN114
      Guangzhou, China
      Completed
      Site CN118
      Hefei, China
      Completed
      Site CN123
      Huangpu Qu, China
      Completed
      Site CN107
      Hangzhou, China
      Active, not recruiting
      Site CN103
      Beijing, China

      Frequently Asked Questions

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      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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