Study summary

The purpose of the phase 1 portion (dose escalation) of the study will be to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) is to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study will also assess safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3 inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assess the acceptability as well as palatability of the formulation.

One cycle is defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have

the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).

Additional Study Details

Phase
Phase 1/Phase 2
Product
  • gilteritinib
  • fludarabine
  • cytarabine
  • granulocyte colony-stimulating factor (G-CSF)
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    9
    Show Additional Study Details

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)? 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

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

      Contact Us
      Contact Us
      Withdrawn
      Site CA15001
      Montreal, Quebec, Canada, H3T 1C5
      Terminated
      Site GB44001
      Birmingham, United Kingdom, B4 6NH
      Terminated
      SIte IT39001
      Roma, Italy, 165
      Terminated
      Site DE49004
      Essen, Nordrhein-Westfalen, Germany, 45147
      Withdrawn
      Site DE49003
      Regensburg, Bayern, Germany, 93053
      Withdrawn
      Site GB44003
      Glasgow, United Kingdom, G51 4TF
      Withdrawn
      Site IT39002
      Monza, Italy, 20900
      Withdrawn
      Site IT39003
      Bologna, Italy, 40138
      Withdrawn
      Site DE49001
      Halle (Saale), Sachsen-Anhalt, Germany, 06120
      Withdrawn
      Site ES34003
      Sevilla, Spain, 41013
      Withdrawn
      Site DE49002
      Freiburg, Baden-Württemberg, Germany, 79106
      Terminated
      Site GB44005
      Cardiff, United Kingdom, CF14 4XW
      Withdrawn
      Site GB44006
      Bristol, United Kingdom, BS2 8BJ
      Terminated
      Site ES34001
      Barcelona, Spain, 08950
      Withdrawn
      Site ES34002
      Barcelona, Spain, 08950
      Withdrawn
      Sarah Cannon Research Institute
      Nashville, TN, United States, 37203
      Withdrawn
      Cincinnati Children's Hospital Medical Center
      Cincinnati, OH, United States, 45229
      Withdrawn
      The Children's Hospital of Philadelphia (CHOP)
      Philadelphia, PA, United States, 19104
      Terminated
      St. Jude Children's Research Hospital
      Memphis, TN, United States, 38105
      Terminated
      Site UK44007
      Sutton, United Kingdom
      Withdrawn
      Site FR33005
      Paris, France
      Withdrawn
      Site FR33006
      Paris, France
      Withdrawn
      Site FR33004
      Marseille cedex 05, France
      Withdrawn
      Site FR33003
      Bordeaux, France
      Withdrawn
      Site FR33002
      Vandoeuvre-Lès-Nancy, France

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      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.

      Will I have to stop my current treatment to participate in a clinical trial?

      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.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

      Explore More

      1

      What are clinical trials?

      2

      Why are Clinical Trials Important?

      3

      Why Participate in a Clinical Trial?