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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080224925

Registered date:18/10/2019

A Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia.

Basic Information

Recruitment status completed
Health condition(s) or Problem(s) studiedFLT3-mutated Acute Myeloid Leukemia (AML) patients
Date of first enrollment27/02/2020
Target sample size84
Countries of recruitmentJapan,South Korea,Taiwan
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : Giltertinib fumarate (ASP2215) INN of investigational material : gilteritinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Administered orally once a day at the specified dosage level. Induction therapy: Days 8 - 21 of each cycle, Consolidation therapy: Days 1 - 14 of each cycle, Maintenance therapy: Daily Generic name etc : Idarubicin hydrochloride INN of investigational material : idarubicin Therapeutic category code : 423 Antitumor antibiotics and preparations Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : cytarabine Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : Administered intravenously at the following doses. Induction therapy: 12 mg/m^2/day from Days 1 to 3 of each cycle control material(s) Generic name etc : Cytarabine INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : Administered intravenously at the following doses. Induction therapy: 100 mg/m^2/day from days 1 to 7 of each cycle, consolidation therapy: 1.5 g/m^2 x 2/day on days 1, 3, and 5 of each cycle

Outcome(s)

Primary OutcomeEfficacy: Complete remission (CR) rate after induction therapy period
Secondary OutcomePharmacokinetics parameters Overall survival (OS) Event-free survival (EFS) Relapse free survival (RFS) CR rate after each treatment therapy CR rate without minimal residual disease (MRD) after each treatment therapy Complete remission with partial hematological recovery (CRh) rate after each treatment therapy Composite complete remission (CRc) rate after each treatment therapy CR/CRh rate after each treatment therapy Duration of CR, CRh, CR/CRh and CRc Duration of response Adverse events (AEs), safety laboratory tests, vital signs, and electrocardiogram (ECGs).

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) according to World Health Organization (WHO) classification (2017) documented within 28 days prior to enrollment. 2.Subject is positive for FLT3-ITD and/or TKD mutation in bone marrow or whole blood as determined by the central lab. Registration by the local lab result is not acceptable. 3. Subject has an eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1. Subject who has an ECOG PS 2 is eligible only if the primary disease related symptoms such as pneumonia and febrile neutropenia are the cause of PS score. 4. Subject is suitable for oral administration of ASP2215. 5. Female subject is not pregnant and at least 1 of the following conditions apply: a. Not a woman of childbearing potential (WOCBP) b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 180 days after final study treatment administration. 6. 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. 7. Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration. 8. Male subject and their female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and continue throughout the study period and for 120 days after the final study drug administration. 9. Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration. 10. Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 120 days after the final study treatment administration. 11. Subject agrees not to participate in another interventional study while on treatment. 12. Subject must meet the following criteria as indicated on the clinical laboratory tests: a. Serum creatinine <= 1.5 x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 50 mL/min/1.73m^2 as calculated with the 4-parameter Modification of Diet in Renal Disease (MDRD) equation. b. Serum total bilirubin <= 2.5 mg/dL (43 micromol/L), except for subjects with Gilbert's syndrome. c. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), 3 x ULN. If liver abnormality by the primary disease is suspected, subject may be pre-registered to initiate the chemotherapy. Prior to registration, AST/ALT values must meet the criteria to continue the study. d. Serum magnesium >= institutional lower limit of normal (LLN). Subject may pre-register without magnesium value, but subject must meet the criteria prior to the full registration on Day 8. e. Serum potassium >= institutional lower limit of normal (LLN).
Exclude criteria1. Subject was diagnosed with acute promyelocytic leukemia (APL). 2. Subject has known breakpoint cluster region-abelson (BCR-ABL) positive leukemia (chronic myelogenous leukemia in blast crisis). 3. Subject has therapy-related AML. 4. Subject has active malignant tumors other than AML. 5. Subject has received previous therapy for AML, with the exception of the following: - Emergency leukapheresis - Emergency treatment for hyperleukocytosis with hydroxyurea for <= 10 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. 6. Subject has QTcF interval > 450 ms (average of triplicate determinations based on central reading). 7. Subject with long QT syndrome. 8. Subject has clinically active central nervous system leukemia. 9. Subject has had major surgery within 4 weeks prior to the first study dose. 10. Subject has radiation therapy within 4 weeks prior to the first study dose. 11. Subject has immediate life-threatening, severe complications of leukemia such as severe uncontrolled bleeding and/or severe disseminated intravascular coagulation 12. Subject is known to have human immunodeficiency virus infection. 13. Subject has active hepatitis B or C. 14. Subject has an uncontrolled infection. An infection controlled with an approved or closely monitored antibiotic/antiviral/antifungal treatment is allowed. 15. Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure of NYHA class 3 or 4 and echocardiogram (ECHO) or Multiple Gate Acquisition (MUGA) scan performed within 3 months prior to screening or at screening showed a left ventricular ejection fraction (LVEF) of < 45%. 16. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A. 17. Subject requires treatment with concomitant drugs that target serotonin 5HT2B receptors or sigma nonspecific receptors, with the exception of drugs that are considered absolutely essential for treatment of the subject. 18. 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. 19. Subject has prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent >= 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed. 20. Subject has any condition which makes the subject unsuitable for study participation.

Related Information

Contact

Public contact
Name
Address 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo
Telephone +81-120-189-371
E-mail clinicaltrialregistration@astellas.com
Affiliation Astellas Pharma Inc
Scientific contact
Name
Address 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo
Telephone +81-120-189-371
E-mail clinicaltrialregistration@astellas.com
Affiliation Astellas Pharma Inc.