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Protocol Number2215-CL-0201
NCT Number(ClinicalTrials.gov Identfier)NCT02752035

2016-07-31 - 2022-06-30

Phase II/III

Recruiting2

Terminated7

ICD-10C92

Myeloid leukemia

A Phase 2/3 Multicenter, Open-label, 3 arm, 2 stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Astellas Pharma Global Development, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Tsai-Yun Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳功深 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Shang-Wen Chen Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Tzeon-jye Chiou Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Chung Kao Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Sheng-chieh Chou Division of Others -
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 滕傑林 Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Acute Myeloid Leukemia (AML)

Objectives

The primary objective is to: ● Determine the efficacy superiority of ASP2215 and/or ASP2215 plus azacitidine versus azacitidine as measured by overall survival (OS). The key secondary objective is to: ● Determine the efficacy superiority of ASP2215 and/or ASP2215 plus azacitidine versus azacitidine as measured by event-free survival (EFS). The additional secondary objectives are to: Evaluate the safety and efficacy of ASP2215 therapy and/or ASP2215 plus azacitidine versus azacitidine in terms of: ● Complete remission (CR) rate ● Leukemia-free survival (LFS) ● Duration of remission ● Composite complete remission (CRc) rate ● Patient reported fatigue (Brief Fatigue Inventory [BFI]) ● Adverse events (AEs), clinical laboratory results, physical examinations, vital signs, electrocardiograms (ECGs), ophthalmologic examinations and Eastern Cooperative Oncology Group (ECOG) performance scores

Test Drug

ASP2215

Active Ingredient

ASP2215

Dosage Form

Tablet

Dosage

40

Endpoints

Primary Endpoint
Primary Efficacy Endpoint:
• OS
Secondary Endpoints
Key Secondary Efficacy Endpoint:
• EFS
Secondary Efficacy Endpoints:
• Best response
• LFS
• Duration of remission
• Patient reported fatigue from BFI
Safety Endpoints:
• AEs
• Clinical laboratory (serum chemistry, hematology, coagulation and urinalysis) results
• Vital sign measurements
• Ophthalmology assessments
• ECGs
• ECOG performance scores
Exploratory Endpoints
• Transplantation
• MRD measured by change in FLT3 mutation allelic frequency compared to baseline.
• FLT3 gene mutation status
o Mutation types and frequency
o Relationship to efficacy and safety
o Mechanisms of acquired resistance
• Resource utilization including hospitalization, blood transfusion, antibiotic intravenous infusions, medication for AEs and opioid usage
• FACIT-Dys-SF assessments
• FACT-Leu and dizziness and mouth sores items
• EQ-5D-5L assessments
• Pharmacogenomics

Inclution Criteria

Subject is eligible for the study if all of the following apply:
1. Institutional Review Board-/Independent Ethics Committee-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act Authorization for United States sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Subject is considered an adult according to local regulation at the time of obtaining informed consent.
3. Subject has a diagnosis of previously-untreated AML according to World Health Organization classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
4. Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD] [D835/I836] mutation) in bone marrow or whole blood as determined by central laboratory.
5. Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
a) Subject is ≥ 75 years of age.
b) Subject has any of the following comorbidities:
i Congestive heart failure or ejection fraction (EF) ≤ 50%;
ii Creatinine > 2 mg/dL (177 µmol/L), dialysis or prior renal transplant
iii ECOG performance status ≥ 3;
iv Prior or current malignancy that does not require concurrent treatment;
v Subject has received a cumulative anthracycline dose above 400 mg/m2.
6. Subject must meet the following criteria as indicated on the clinical laboratory tests:
• Serum aspartate aminotransferase and alanine aminotransferase  2.5  upper limit normal (ULN)
• Serum total bilirubin  1.5  ULN
• Serum potassium ≥ lower limit of normal (LLN)
• Serum magnesium ≥ LLN
7. Subject is suitable for oral administration of study drug.
8. Female subject must either:
• Be of nonchildbearing potential:
• Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
• Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
• Or, if of childbearing potential,
• Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
• And have a negative urine pregnancy test at screening
• And, if heterosexually active, agree to consistently use 2 forms of effective contraception per locally accepted standards, 1 of which must be a barrier method, starting at screening and throughout the study period and for 45 days after the final study drug administration.
9. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 45 days after the final study drug administration.
10. Female subject must not donate ova starting at screening and throughout the study period, and for 45 days after the final study drug administration.
11. Male subject and their female partners who are of childbearing potential must be using 2 forms of effective contraception per locally accepted standards, 1 of which must be a barrier method, starting at screening and continue throughout the study period, and for 105 days after the final study drug administration.
12. Male subject must not donate sperm starting at screening and throughout the study period and for 105 days after the final study drug administration.
13. Subject agrees not to participate in another interventional study while on treatment.
Waivers to the inclusion criteria will NOT be allowed.

Exclusion Criteria

Subject will be excluded from participation if any of the following apply:
1. Subject was diagnosed as acute promyelocytic leukemia (APL).
2. Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
3. Subject has received previous therapy for AML, with the exception of the following:
• Emergency leukapheresis
• Hydroxyurea for ≤ 14 days
• Preemptive treatment with retinoic acid prior to exclusion of APL ≤ 7 days
• Growth factor or cytokine support
• Steroids for the treatment of hypersensitivity or transfusion reactions
4. Subject has clinically active central nervous system leukemia.
5. Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of the need for treatment.
6. Subject has clinically significant coagulation abnormality unless secondary to AML in the opinion of the investigator.
7. Subject has had major surgery within 4 weeks prior to the first study dose.
8. Subject has radiation therapy within 4 weeks prior to the first study dose.
9. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A4.
10. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
11. Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
12. Subject has congestive heart failure classified as New York Heart Association Class IV.
13. Subject with mean Fridericia-corrected QT interval (QTcF) > 450 ms at screening based on central reading.
14. Subject with Long QT Syndrome at screening.
15. Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide
(DLCO) ≤ 65%, forced expiratory volume in the first second (FEV1) ≤ 65%, dyspnea at rest or requiring oxygen or any pleural neoplasm.
16. Subject has an active uncontrolled infection. If an infection is present, the patient must be receiving definitive therapy and have no signs of progressing infection. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
17. Subject is known to have human immunodeficiency virus infection.
18. Subject has active hepatitis B or C or other active hepatic disorder.
19. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
Waivers to the exclusion criteria will NOT be allowed.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    250 participants

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