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Astellas Study ID
2215-CL-0303

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

Astellas Study ID
2215-CL-0303
Clinicaltrials.gov ID
NCT03182244
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
CTR20170326
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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
Product
Gilteritinib
Cytarabine
Mitoxantrone
Etoposide
G-CSF
Fludarabine
Type
Interventional
Masking
None (Open Label)
Enrollment number
276
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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.

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  • A patient
  • 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

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    Site RU501
    Saint Petersburg, Russian Federation
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    Site SG403
    Singapore, Singapore
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    Site CN113
    Zhengzhou, China
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    Completed
    Site CN126
    Shanghai, China
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    Site CN133
    Lanzhou, China
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    Completed
    Site MY301
    Johor Bahru, Malaysia
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    Completed
    Site CN108
    Beijing, China
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    Site CN122
    Xi'an, China
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    Site CN117
    Jinan, China
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    Site CN119
    Fuzhou, China
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    Site MY305
    George Town, Malaysia
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    Site TH202
    Khon Kaen, Thailand
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    Site CN128
    Nanjing, China
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    Site MY304
    Kota Kinabalu, Malaysia
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    Site CN105
    Wuhan, China
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    Site TH204
    Chiang Mai, Thailand
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    Site CN120
    Changsha, China
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    Withdrawn
    Site RU503
    Tula, Russian Federation
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    Completed
    Site CN102
    Guangzhou, China
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    Withdrawn
    Site CN112
    Beijing, China
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    Site RU506
    Kemerovo, Russian Federation
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    Site CN110
    Beijing, China
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    Site CN101
    Tianjin, China
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    Completed
    Site MY306
    Ampang, Malaysia
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    Site SG401
    Singapore, Singapore
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    Site RU507
    Saint Petersburg, Russian Federation
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    Site CN109
    Beijing, China
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    Site RU502
    Saint-Petersburg, Russian Federation
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    Site TH205
    Bangkok, Thailand
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    Site RU508
    Moscow, Russian Federation
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    Site MY302
    Kuala Lumpur, Malaysia
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    Site TH201
    Khon Kaen, Thailand
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    Site SG402
    Singapore, Singapore
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    Site TH203
    Bangkok, Thailand
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    Completed
    Site CN129
    Shanghai, China
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    Site CN136
    Zhengzhou, China
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    Active, not recruiting
    Site CN121
    Guangzhou, China
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    Completed
    Site MY303
    Pulau Pinang, Malaysia
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    Completed
    Site RU504
    Krasnoyarsk, Russian Federation
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    Site CN125
    Shenyang, China
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    Completed
    Site RU509
    Moscow, Russian Federation
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    Completed
    Site CN131
    Beijing, China
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    Site CN132
    Zhangzhou, China
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    Completed
    Site CN106
    Qingdao, China
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    Completed
    Site CN130
    Guiyang City, China
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    Completed
    Site CN116
    Changchun, China
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    Completed
    Site CN114
    Guangzhou, China
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    Site CN118
    Hefei, China
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    Completed
    Site CN123
    Huangpu Qu, China
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    Completed
    Site CN107
    Hangzhou, China
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    Active, not recruiting
    Site CN103
    Beijing, China
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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
    Oct 2017 - Dec 2023
    Additional Study Details
    Inclusion Criteria
    • Participant has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.
    • Participant is refractory to or relapsed after first-line AML therapy (with or without HSCT)
      • Refractory to first-line AML therapy is defined as:

      • a. Participant did not achieve CR/CRi/CRp under initial therapy. A participant eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A participant not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this participant.

    • Untreated first hematologic relapse is defined as:

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

    • Participant is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. A participant with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on a local test performed after completion of the last interventional treatment. Participants can be enrolled from a local test result if the participants have any of the following FLT3 mutations: FLT3-internal tandem duplication (ITD), FLT3-tyrosine kinase domain (TKD)/D835 or FLT3-TKD/I836.
    • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    • Participant is eligible for preselected salvage chemotherapy.
    • Participant must meet the following criteria as indicated on the clinical laboratory tests:
      • Serum aspartate aminotransferase (AST) and alanine aminotransferase (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.
    • Participant is suitable for oral administration of study drug.
    • Participant agrees not to participate in another interventional study while on treatment.

      • Inclusion Criteria for COE:

      Participant is eligible for the COE if they continue to meet all inclusion criteria from the main protocol in addition to the following when the participant is evaluated for eligibility to participate in the COE portion of the study:

    • Participant has received study treatment of either LoDAC, MEC or FLAG and has no response or progressive disease.
    • Participant have not received other antileukemic therapy after EOT (hydroxyurea is allowed for the control of peripheral leukemic blasts in participants with leukocytosis).
    • Participant agrees not to participate in another interventional study while on treatment.
    MaximizeExclusion Criteria
    • Participant was diagnosed as acute promyelocytic leukemia.
    • Participant has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
    • Participant has AML secondary to prior chemotherapy for other neoplasms (except for MDS).
    • Participant is in second or later hematologic relapse or has received salvage therapy for refractory disease.
    • Participant has clinically active central nervous system leukemia..
    • Participant has been diagnosed with another malignancy, unless disease-free for at least 5 years. Participants with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Participants with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
    • Participant has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib and midostaurin used in first-line therapy regimen as part of induction, consolidation and/or maintenance).
    • Participant has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation.
    • Participant has had major surgery within 4 weeks prior to the first study dose.
    • Participant has radiation therapy within 4 weeks prior to the first study dose.
    • Participant has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or participant with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram (ECHO) performed within 1 month prior to study entry results in a left ventricular ejection fraction (LVEF) that is ≥ 45%.
    • Participant with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
    • Participant with Long QT Syndrome at Screening.
    • Participant with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal [LLN]).
    • Participant requires treatment with concomitant drugs that are strong inducers of CYP3A.
    • Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the participant.
    • Participant requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.
    • Participant has an active uncontrolled infection.
    • Participant is known to have human immunodeficiency virus infection.
    • Participant has active hepatitis B or C or other active hepatic disorder.
    • Participant has any condition which makes the participant unsuitable for study participation.
    • Participant has active clinically significant (graft-versus-host disease) GVHD or is on treatment with systemic corticosteroids for GVHD.
    • Participant has an FLT3 mutation other than the following: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836.

      • Exclusion Criteria for COE:

      Participant will be excluded from participation in the COE if they meet any of the exclusion criteria listed in the main protocol or when the participant is evaluated for eligibility to participate in the COE portion of the study.

    Frequently Asked Questions

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