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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02752035
Registration number
NCT02752035
Ethics application status
Date submitted
22/04/2016
Date registered
26/04/2016
Date last updated
12/06/2024
Titles & IDs
Public title
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
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Scientific title
A Phase 3 Multicenter, Open-label, 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
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Secondary ID [1]
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2015-001790-41
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Secondary ID [2]
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2215-CL-0201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML)
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Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - gilteritinib
Treatment: Drugs - azacitidine
Experimental: Dose escalation of ASP2215 given with azacitidine - Subjects will be treated with ASP2215 daily (days 1-28) and azacitidine daily for 7 days (days 1-7).
Experimental: Arm A: ASP2215 - Subjects will be treated daily each 28-day cycle.
Experimental: Arm AC: ASP2215 + azacitidine - Subjects will be treated with ASP2215 daily and azacitidine daily for 7 days (days 1-7) each 28-day cycle.
Active comparator: Arm C: azacitidine - Subjects will be treated with azacitidine for 7 days (days 1-7) each 28-day cycle.
Treatment: Drugs: gilteritinib
Tablet, oral
Treatment: Drugs: azacitidine
Subcutaneous injection or intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization until the date of death from any cause.
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Timepoint [1]
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Up to 77 months
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Secondary outcome [1]
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Event free survival (EFS)
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Assessment method [1]
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EFS is defined as the time from the date of randomization until the date of documented relapse from complete remission (CR), treatment failure or death from any cause, whichever occurs first.
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Timepoint [1]
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Up to 77 months
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Secondary outcome [2]
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Best response
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Assessment method [2]
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Best response is defined as the best measured response (in the order of CR, CRp, Cri or treatment failure defined by lack of composite complete remission (CRc)) from all post-baseline visits.
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Timepoint [2]
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Up to 48 months
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Secondary outcome [3]
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Complete remission (CR) rate
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Assessment method [3]
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Complete remission rate is defined as the number of patients with all complete CRs.
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Timepoint [3]
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Up to 48 months
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Secondary outcome [4]
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Composite complete remission (CRc) rate
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Assessment method [4]
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CRc rate is defined as the number of patients with all complete and incomplete CRs (i.e., CR + Complete remission with incomplete platelet recovery (CRp) + Complete remission with incomplete hematologic recovery (Cri)).
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Timepoint [4]
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Up to 48 months
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Secondary outcome [5]
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Complete remission with partial hematologic recovery (CRh) rate
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Assessment method [5]
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CRh rate is defined as the number of patients who achieve CRh at any of the post-baseline visits and do not have best response of CR divided by the number of patients in the analysis population.
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Timepoint [5]
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Up to 48 months
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Secondary outcome [6]
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Complete remission and complete remission with partial hematological recovery (CR/CRh) rate
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Assessment method [6]
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CR/CRh rate is defined as the number of patients who achieve either CR or CRh at any of the post-baseline visits divided by the number of patients in the analysis population.
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Timepoint [6]
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Up to 48 months
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Secondary outcome [7]
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Transfusion conversion rate
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Assessment method [7]
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Transfusion conversion rate is defined as the number of patients who were transfusion dependent at the baseline period but become transfusion independent at the post-baseline period divided by the total number of patients who were transfusion dependent at baseline period.
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Timepoint [7]
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Up to 49 months
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Secondary outcome [8]
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Transfusion maintenance rate
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Assessment method [8]
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Transfusion maintenance rate is defined as the number of patients who were transfusion independent at the baseline period and still maintain transfusion independence at the post-baseline period divided by the number of patients who were transfusion independent at baseline period.
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Timepoint [8]
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Up to 49 months
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Secondary outcome [9]
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Leukemia free survival (LFS)
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Assessment method [9]
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LFS is defined as the time from the date of first composite complete remission (CRc) until the date of documented relapse or death for subjects who achieve CRc.
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Timepoint [9]
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Up to 77 months
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Secondary outcome [10]
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Duration of remission
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Assessment method [10]
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Duration of remission includes duration of CRc, CR, Cri, CRp and response (CRc + partial response \[PR\]). Duration of CRc is defined as the time from the date of first CRc until the date of documented relapse for subjects who achieve CRc. Duration of remission is similarly defined for CR, Cri and CRp.
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Timepoint [10]
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Up to 48 months
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Secondary outcome [11]
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Participant reported fatigue from Brief Fatigue Inventory (BFI)
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Assessment method [11]
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The BFI was developed to assess the severity of fatigue and the impact of fatigue on daily functioning in subjects with fatigue due to cancer and cancer treatment The BFI inventory has 9 items and a 24-hour recall. A global fatigue score is computed by averaging the 9 items.
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Timepoint [11]
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Up to 48 months
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Secondary outcome [12]
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Safety assessed by adverse events (AEs)
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Assessment method [12]
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Timepoint [12]
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Up to 49 months
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Secondary outcome [13]
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Number of participants with abnormal laboratory values and/or adverse events related to treatment
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Assessment method [13]
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Timepoint [13]
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Up to 48 months
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Secondary outcome [14]
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Number of participants with abnormal vital signs and/or adverse events related to treatment
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Assessment method [14]
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Timepoint [14]
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Up to 48 months
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Secondary outcome [15]
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Number of participants with Physical Exam abnormalities and/or adverse events
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Assessment method [15]
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Number of participants with potentially clinically significant physical exam values.
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Timepoint [15]
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Up to 48 months
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Secondary outcome [16]
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Safety assessed by electrocardiograms (ECGs)
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Assessment method [16]
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The 12-lead ECGs will be recorded in triplicate (3 separate ECGs) and transmitted electronically for central reading. The mean of the triplicate ECG from central read will be used for all final treatment decisions and adverse event reporting.
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Timepoint [16]
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Up to 48 months
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Secondary outcome [17]
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Eastern Cooperative Oncology Group (ECOG) performance status score
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Assessment method [17]
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ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2= Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead. 0=Best status; 5=Worst status.
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Timepoint [17]
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Up to 48 months
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Eligibility
Key inclusion criteria
* Subject is considered an adult according to local regulation at the time of obtaining informed consent.
* Subject has a diagnosis of previously-untreated AML according to World Health Organization (WHO) classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
* Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD] [D835/I836] mutation) (or for Korea only: ITD alone or ITD with concurrent TKD activating mutation) in bone marrow or whole blood as determined by central laboratory. Note: Only requirement of FLT3 mutation assessment by central laboratory is only applicable to the randomization portion of the study.
* Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
* Subject is = 65 years of age and ineligible for intensive induction chemotherapy.
* Subject is = 18 to 64 years of age and has any of the following comorbidities: [Ex-US Only]: Congestive heart failure (New York Heart Association {NYHA} class = 3) or ejection fraction (Ef) = 50%; [US Only]: Severe cardiac disorder e.g. congestive heart failure (New York Heart Association [NYHA] class = 3) requiring treatment, ejection fraction = 50%, or chronic stable angina; [Ex-US Only]: Creatinine > 2 mg/dL (177 µmol/L), dialysis or prior renal transplant; [US Only]: Creatinine clearance < 45 mL/min; ECOG performance status = 2;
* [Ex-US Only]: Known pulmonary disease with decreased diffusion capacity of lung for carbon monoxide (DLCO) and/or requiring oxygen = 2 liters per minute; [US Only] Severe pulmonary disorder (e.g., diffusion capacity of lung for carbon monoxide [DLCO] = 65% or forced expiratory volume in the first second [FEV1] = 65%); Prior or current malignancy that does not require concurrent treatment; Subject has received a cumulative anthracycline dose above 400 mg/m2 of doxorubicin (or cumulative maximum dose of another anthracycline). Any other comorbidity incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor during screening and before randomization.
* Subject must meet the following criteria as indicated on the clinical laboratory tests:
* Serum AST and ALT = 3.0 x Institutional upper limit of normal (ULN)
* Serum total bilirubin = 1.5 x Institutional ULN
* Serum potassium = Institutional lower limit of normal (LLN)
* Serum magnesium = Institutional LLN Repletion of potassium and magnesium levels during the screening period is allowed.
* Subject is suitable for oral administration of study drug.
* Female subject is eligible to participate if female subject is not pregnant and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP); OR
* WOCBP agrees to follow the contraceptive guidance starting at screening and continue throughout the study 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 60 days after the final study drug administration.
* Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
* Male subject with female partners of childbearing potential must agree to use contraception as detailed in Contraception Requirements, starting at screening and continue throughout the study period, and for 120 days after the final study drug administration.
* Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.
* Subject agrees not to participate in another interventional study while on treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject was diagnosed as acute promyelocytic leukemia (APL).
* Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
* Subject has received previous therapy for AML, with the exception of the following:
* Emergency leukapheresis
* Hydroxyurea
* Preemptive treatment with retinoic acid prior to exclusion of APL = 7 days
* Growth factor or cytokine support
* Steroids
* Subject has clinically active central nervous system leukemia.
* Subject has been diagnosed with another malignancy that requires concurrent treatment (with the exception of hormone therapy limited to those therapies that prevent recurrence and/or spread of cancer) or hepatic malignancy regardless of need for treatment.
* Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 CYP3A/P-glycoprotein (P-gp).
* Subject 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 subject.
* Subject requires treatment with concomitant drugs that target serotonin 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.
* Subject has congestive heart failure classified as New York Heart Association Class IV.
* Subject with mean Fridericia-corrected QT interval (QTcF) > 480 ms at screening based on central reading.
* Subject with a history of Long QT Syndrome at screening.
* [Ex-US Only]: Subject has known pulmonary function tests with diffusion capacity of lung for carbon monoxide (DLCO) = 50%, forced expiratory volume in the first second (FEV1) = 60%, dyspnea at rest or requiring oxygen or any pleural neoplasm (Transient use of supplemental oxygen is allowed.)
* Subject has active hepatitis B or C or other active hepatic disorder.
* Subjects with positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B DNA are not eligible.
* Subjects with negative HBsAg, positive hepatitis B core antibody and negative hepatitis B surface antibody will be eligible if hepatitis B DNA is undetectable.
* Subjects with antibodies to hepatitis C virus will be eligible if hepatitis C RNA is undetectable
* Subject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.
* Subject has a known or suspected hypersensitivity to ASP2215, azacitidine or any components of the formulations used.
* [US Only]: Subject is = 65 to 74 years of age, suitable for and willing to receive intensive induction chemotherapy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
183
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Site AU61004 - Liverpool
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Recruitment hospital [2]
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Site AU61008 - Adelaide
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Recruitment hospital [3]
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Site AU61007 - Geelong
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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SA 5000 - Adelaide
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Illinois
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United States of America
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Missouri
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New Jersey
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United States of America
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New York
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United States of America
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South Carolina
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United States of America
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Utah
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Belgium
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Bruxelles-Capitale, Region De
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Belgium
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Bruxelles
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Belgium
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Gent
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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France
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Gard
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France
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Gironde
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France
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Haute-Normandie
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France
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Herault
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France
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Ille-et-Vilaine
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Loire-Atlantique
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France
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Nord
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Rhone
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Sarthe
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France
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Vienne
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France
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Angers
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France
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Bayonne
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France
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Lille cedex
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France
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Lille
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Hessen
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Germany
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Niedersachsen
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Ancona
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Italy
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Bologna
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Italy
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Firenze
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Italy
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Milano
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Italy
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Monza
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Italy
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Napoli
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Italy
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Novara
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Italy
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Palermo
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Italy
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Pavia
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Italy
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San Giovanni Rotondo
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Aichi
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Ehime
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Hyogo
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Ibaraki
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Ishikawa
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Kanagawa
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Miyagi
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Okayama
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Tokyo
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Chiba
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Fukuoka
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Gifu
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Kumamoto
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Kyoto
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Nagasaki
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Japan
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Osaka
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Japan
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Tokushima
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Japan
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Toyama
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Korea, Republic of
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Incheon Gwang'yeogsiv
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Ulsan Gwang'yeogsi
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Korea, Republic of
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Busan
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Korea, Republic of
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Hwasun-gun
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Poland
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Lubelskie
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Mazowieckie
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Opolskie
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Warminsko-mazurskie
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Spain
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Asturias
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Baleares
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Barcelona
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Caceres
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Spain
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Madrid
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Spain
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Valencia
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Taiwan
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Kaohsiung
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Taiwan
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Kwei Shan Hsiang
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Astellas Pharma Global Development, Inc.
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Summary
Brief summary
This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster.
For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster.
This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.
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Trial website
https://clinicaltrials.gov/study/NCT02752035
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Contacts
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Medical Director
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Astellas Pharma Global Development, Inc.
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT02752035
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