A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) -

ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.0 个研究点目标入组 114 人开始时间: 2021年2月4日最近更新: 2021年4月5日

适应症

试验速览

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•1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent and privacy language as required per national regulations (e.g., Health Insurance Portability and Accountability Act Authorization for US sites) must be obtained from the subject or subject's parent or legal guardian and if required child assent prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
•2. Subject is positive for the FLT3/ITD mutation in bone marrow or blood as determined by the local institution.
•3. Subject is aged >= 6 months and < 21 years of age at the time of signing informed consent and/or assent, as applicable.
•4. Subject has a diagnosis of AML according to The French–American–British (FAB) classification with >= 5% blasts in the bone marrow, with or without extramedullary disease (except subjects with active central nervous system [CNS] leukemia).
•5. Subject has Karnofsky score >= 50 (if the subject is of >= 16 years of age) or Lansky score of >= 50 (if the subject is < 16 years of age).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Subject has active CNS leukemia.
•2. Subject has uncontrolled or significant cardiovascular disease
•3. Subject has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The subject needs to be off pressors and have negative blood cultures for 48 hours.
•5. Subject is receiving or plans to receive concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
•6. Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids and is receiving > 0.5 mg/kg of prednisone (or equivalent) daily dose for GVHD.
•7. Subject has active malignant tumors other than AML.
•8. Subject has hypokalemia and/or hypomagnesemia at Screening (defined as values below institutional lower limit of normal [LLN]). Repletion of potassium and magnesium levels during the screening period is allowed.
•9. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
•10. Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting gilteritinib.

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