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Astellas Study ID
2215-CL-1101

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)

Astellas Study ID
2215-CL-1101
Clinicaltrials.gov ID
NCT03730012
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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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
Product
gilteritinib
atezolizumab
Type
Interventional
Masking
None (Open Label)
Enrollment number
11
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Study documents

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

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  • Belgium
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  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
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  • India
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  • Puerto Rico
  • Republic of Korea
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  • 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
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    Completed
    Northwestern University
    Chicago, IL, United States, 60611
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    Completed
    The Ohio State University Comprehensive Cancer Center (OSUCCC)
    Columbus, OH, United States, 43210
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    Completed
    Vanderbilt Ingram Cancer Center
    Nashville, TN, United States, 37232
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    Withdrawn
    Medical University of South Carolina (MUSC) - Hollings Cancer Center (HCC)
    Charleston, SC, United States, 29425
    Contact Us
    Completed
    Roswell Park Cancer Institute (RPCI)
    Buffalo, NY, United States, 14263
    Contact Us
    Completed
    Weill Cornell Medical College
    New York, NY, United States, 10065
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    Completed
    Medical College of Wisconsin
    Milwaukee, WI, United States, 53226
    Contact Us
    Completed
    University of Kentucky
    Lexington, KY, United States, 40536
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    Completed
    University of Chicago
    Chicago, IL, United States, 60037
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    Completed
    University of Texas MD Anderson
    Houston, TX, United States, 77030
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    Completed
    Columbia University Medical Center
    New York, NY, United States, 10032
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    Completed
    Simmons Comprehensive Cancer Center
    Dallas, TX, United States, 75390
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    Completed
    Ronald Reagan UCLA Medical Center
    Los Angeles, CA, United States, 90095
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    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Leukemia - AML
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Jun 2019 - May 2021
    Additional Study Details
    Inclusion Criteria
    • Subject is considered an adult according to local regulation at the time of signing informed consent form (ICF).
    • Subject has defined AML by the World Health Organization (WHO) criteria (2017) and fulfills one of the following:
      • Refractory to at least 1 cycle of induction chemotherapy
      • Relapsed after achieving remission with a prior therapy
    • Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject’s last interventional treatment.
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening.
    • Subject must meet the following criteria as indicated on the clinical laboratory tests:
      • Serum Aspartate aminotransferase (AST) and Alanine Aminotransferease (ALT) ≤ 2.5 x upper limit of normal (ULN)
      • Serum total bilirubin (TBL) ≤ 1.5 x ULN
      • Serum creatinine ≤ 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
    • Subject is suitable for oral administration of study drug.
    • A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
      • Not a woman of childbearing potential (WOCBP) OR
      • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study drug administration.
    • Female subject must agree not to breastfeed starting at screening and throughout the study period, and for at least 180 days after the final study drug administration.
    • Female subject must not donate ova starting at screening and throughout the study period, and for at least 180 days after the final study drug administration.
    • A male subject must not donate sperm starting at screening and throughout the treatment

      • period, and for at least 120 days after the final study drug administration.

    • A male subject with female partner(s) of child-bearing potential must agree to use contraception during the treatment period, and for at least 120 days after the final study drug administration.
    • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the treatment period, and for 120 days after the final study drug administration.
    • Subject agrees not to participate in another investigational study while on treatment.
    MaximizeExclusion Criteria
    • Subject was diagnosed as acute promyelocytic leukemia.
    • Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
    • Subject has AML secondary to prior chemotherapy for other neoplasms (except for myelodysplastic syndrome).
    • Subject has clinically active central nervous system leukemia.
    • Subject has uncontrolled or significant cardiovascular disease, including:
      • A myocardial infarction within 12 months
      • Uncontrolled angina within 6 months
      • History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes) or any history of arrhythmia
      • Uncontrolled hypertension
    • Subject has baseline left ventricular ejection fraction that is ≥ 45%.
    • Subject has mean triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
    • Subject has congenital or acquired Long QT Syndrome at screening.
    • Subject has hypokalemia and/or hypomagnesemia at screening.
    • Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of the need for treatment.
    • Subject has clinically significant coagulation abnormality unless secondary to AML.
    • Subject is receiving or plans to receive concomitant chemotherapy or immunotherapy.
    • Subject has had major surgery within 4 weeks prior to the first study dose.
    • Subject has radiation therapy within 4 weeks prior to the first study dose.
    • Subject requires treatment with concomitant drugs that are strong inducers of Cytochrome P450 (CYP3A).
    • Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide ≤ 65%, forced expiratory volume in the first second (FEV1) ≤ 65%, dyspnea at rest or requiring oxygen or any pleural neoplasm.
    • Subject with systemic fungal, bacterial, viral or other uncontrolled infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. Subject needs to be off pressors and have negative blood cultures for 48 hours.
    • Subject has not recovered from any prior therapy related toxicities.
    • Subject is known to have human immunodeficiency virus infection.
    • Subject has active hepatitis B or C or other active hepatic disorder.
    • Subject has previously been treated with gilteritinib, quizartinib or crenolanib (will only apply to subjects enrolled in the phase 2 portion of the study).
    • Subject has active clinically significant graft-versus-host disease (GVHD) or is on treatment with systemic corticosteroids for GVHD.
    • Subject has relapsed after allogeneic hematopoietic stem cell transplant (HCST).
    • Subject has an active autoimmune disorder that makes the subject unsuitable for study treatment or participation.
    • Subject has any condition that makes the subject unsuitable for study participation.

    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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    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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