Study summary

The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and to determine the composite complete remission (CRc) rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab.

This study also evaluated pharmacokinetics (PK), response to treatment, remission and survival. Adverse events (AEs), clinical laboratory results, vital signs, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status scores were also assessed.

Additional Study Details

Phase
Phase 1/Phase 2
Product
  • gilteritinib
  • atezolizumab
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    11
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FMS-like tyrosine kinase (FLT3) Mutated 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
      Completed
      Northwestern University
      Chicago, IL, United States, 60611
      Completed
      The Ohio State University Comprehensive Cancer Center (OSUCCC)
      Columbus, OH, United States, 43210
      Completed
      Vanderbilt Ingram Cancer Center
      Nashville, TN, United States, 37232
      Withdrawn
      Medical University of South Carolina (MUSC) - Hollings Cancer Center (HCC)
      Charleston, SC, United States, 29425
      Completed
      Roswell Park Cancer Institute (RPCI)
      Buffalo, NY, United States, 14263
      Completed
      Weill Cornell Medical College
      New York, NY, United States, 10065
      Completed
      Medical College of Wisconsin
      Milwaukee, WI, United States, 53226
      Completed
      University of Kentucky
      Lexington, KY, United States, 40536
      Completed
      University of Chicago
      Chicago, IL, United States, 60037
      Completed
      University of Texas MD Anderson
      Houston, TX, United States, 77030
      Completed
      Columbia University Medical Center
      New York, NY, United States, 10032
      Completed
      Simmons Comprehensive Cancer Center
      Dallas, TX, United States, 75390
      Completed
      Ronald Reagan UCLA Medical Center
      Los Angeles, CA, United States, 90095

      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.

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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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