EUCTR2015-000140-42-IT进行中（未招募）1 期
A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 versusSalvage Chemotherapy in Patients with Relapsed or Refractory AcuteMyeloid Leukemia (AML) with FLT3 Mutation - ADMIRA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 369
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject is eligible for the study if all of the following apply:
- •1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] 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 signing informed consent.
- •3. Subject has a diagnosis of primary AML or AML secondary to MDS according to World Health Organization (WHO) classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
- •4. Subject is refractory to or relapsed after first-line AML therapy (with or without HSCT) (see definition of line of therapy in Appendix 12.6).
- •¿ Refractory to first-line AML therapy is defined as:
- •Subject did not achieve CR/CRi/CRp under initial therapy. A subject 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 subject 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 subject as per investigator's assessment.
- •¿ Untreated first hematologic relapse is defined as:
- •Subject must have achieved a CR/CRi/CRp (as defined by [Cheson et al, 2003], see Section 5.3) with first-line treatment and has hematologic relapse.
- •5. Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. In the investigator's opinion, a subject 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. Subjects can be enrolled from a local test result if they have any of the following FLT3 mutations: FLT3- ITD, FLT3-TKD/D835 or FLT3-TKD/I836.
- •6. Subject has an ECOG performance status = 2.
- •7. Subject is eligible for preselected salvage chemotherapy according to investigator assessment.
- •8. Subject must meet the following criteria as indicated on the clinical laboratory tests:
- •¿ Serum AST and 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.
- •9. Subject is suitable for oral administration of study drug.
- •10. Female subject must either:
- •Be of non-childbearing potential:
- •¿ Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
- •¿ Documented as surgically sterile (at least 1 month prior to screening) Or, if of childbearing potential,
- •¿ Agree not to try to become pregnant during the study and for 180 days
- •after the final study drug administration
- •¿ And have a negative urine pregnancy test at screening
- •¿ And, if heterosexually active, agree to consistently use highly effective contraception per locally accepted standards in addition to a barrier method starting at screening and throughout the study period and for 180 days after the final study drug administration.
- •11. Female subject must agree not to breastfeed at screening and throughout the study period and for 60 days
排除标准
- •Subject will be excluded from participation if any of the following apply:
- •1. Subject was diagnosed as acute promyelocytic leukemia.
- •2. Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
- •3. Subject has AML secondary to prior chemotherapy for other neoplasms (except for MDS).
- •4. Subject is in second or later hematologic relapse or has received salvage therapy for refractory
- •5. Subject has clinically active central nervous system leukemia.
- •6. Subject has been diagnosed with another malignancy, unless disease-free for at least 5 years.
- •Subjects 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. Subjects 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.
- •7. Subject 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).
- •8. Subject has clinically significant abnormality of coagulation profile, such as disseminated
- •intravascular coagulation.
- •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 congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject
- •with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening
- •echocardiogram performed within 1 month prior to study entry results in a left ventricular
- •ejection fraction that is = 45%.
- •12. Subjects with mean of triplicate Fridericia-corrected QT interval (QTcF) > 450 ms at Screening
- •based on central reading.
- •13. Subjects with Long QT Syndrome at Screening.
- •14. Subjects with hypokalemia and hypomagnesemia at Screening (defined as values below lower
- •limit of normal [LLN]).
- •15. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450
- •16. 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.
- •17. Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine
- •receptor 1 (5HT
- •R) or 5-hydroxytryptamine receptor 2B (5HT
- •R) or sigma nonspecific receptor
- •with the exception of drugs that are considered absolutely essential for the care of the subject.
- •18. Subject has an active uncontrolled infection.
- •19. Subject is known to have human immunodeficiency virus infection.
- •20. Subject has active hepatitis B or C or other active hepatic disorder.
- •21. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for
- •study participation.
- •22. Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids
- •23. Subject has an FLT3 mutation other than the following: FLT3-ITD, FLT3-TKD/D835 or
- •FLT3-TKD/I836.
- •Waivers to the exclusion criteria will NOT be allowed.
研究者
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