EUCTR2021-000761-33-PL进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •1. Adults 18 to 75 years with previously untreated de novo AML, AML with MDS features, or therapy-related AML.
- •2. NPM1-mutated disease documented in a local or the Sponsor’s central testing facility.
- •Note: Subjects with concurrent FLT3 mutation but without access to midostaurin (eg, either for lack of health authority approval or reimbursement) may also enroll; subjects with a concurrent FLT3 mutation will not be allowed to receive a FLT3 inhibitor at any time during the study treatment period.
- •Note: Subjects with local test results for NPM1-m (and/or FLT3 mutational status) may enroll, provided appropriate samples are sent to the Sponsor’s central testing facility for NPM1-m companion diagnostic development (see Section 4.1).
- •3.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0, 1, or 2.
- •4.Adequate hepatic and renal function defined as:
- •a.Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the upper limit of normal (ULN), except those with hepatic involvement by AML, as documented by either computed tomography (CT) or ultrasound, in whom levels of AST and ALT < 5 times ULN are acceptable; total bilirubin < 1.5 times ULN unless elevated due to Gilbert’s Disease or hemolysis.
- •b.Calculated creatinine clearance > 40 mL/min or serum creatinine < 1.5 times ULN.
- •5.Prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) = 1.5 x ULN unless receiving therapeutic anticoagulation. Note: Transition from a Vitamin K or Factor Xa antagonist to a low-molecular weight heparin preparation is recommended prior to the start of induction chemotherapy (see Appendix 8 for guidelines on anticoagulation management).
- •6.Left ventricular ejection fraction = 45% confirmed by echocardiogram (ECHO) or multi gated acquisition (MUGA) scan.
- •7.Negative serum ß-HCG test in women of childbearing potential (WOCBP).
- •8.For WOCBP, willingness to abstain from heterosexual intercourse OR to use a protocol-recommended method of contraception from 7 days prior to C1D1 throughout the study treatment period and for 90 days following the last dose of ENTO/placebo or as recommended in the prescribing information for other co-administered study drugs (whichever is later).
- •9.For male subjects with female sexual partners of childbearing potential, willingness to abstain from heterosexual intercourse OR use a protocol recommended method of contraception beginning 7 days prior to C1D1 throughout the study treatment period and for 90 days following the last dose of ENTO/placebo or as recommended in the prescribing information for other co-administered study drugs (whichever is later), AND to refrain from sperm donation from the start of study treatment throughout the study treatment period and for 90 days following the last dose of ENTO/placebo or as recommended in the prescribing information for other co-administered study drugs (whichever is later).
- •10.Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •11.Willingness to comply with scheduled study visits, procedures, and treatment plan.
- •Are the trial subjects under 18? no
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.Isolated myeloid sarcoma (ie, participants must have peripheral blood and/or bone marrow involvement by AML) or acute promyelocytic leukemia.
- •2.Known central nervous system (CNS) involvement with leukemia.
- •3.Active infection with hepatitis B, C, or known human immunodeficiency virus (HIV).
- •Note: Subjects who are positive for hepatitis B surface antigen (HBsAg) are ineligible. Those who are seropositive for hepatitis B core antibody (anti-HBc) may enroll but must agree to receive hepatitis B virus (HBV) prophylaxis during the study treatment period and undergo regular surveillance for HBV reactivation at least once every 3 months. Subjects who have received curative therapy for prior HCV infection and who are seropositive for hepatitis C antibody (anti-HCV), may enroll, however must undergo regular surveillance monitoring for HCV reactivation.
- •4.Known active coronavirus disease 2019 (COVID-19) either symptomatic or asymptomatic, as determined by nasopharyngeal swab for severe acute respiratory syndrome (SARS) coronavirus 2 (SARS CoV-2) RNA or antigen.
- •Note: Subjects with a history of SARS-CoV-2 nasopharyngeal carriage (either with or without symptoms), who have subsequently tested negative on follow-up nasopharyngeal swab and are without signs or symptoms of COVID-19 may enroll. Subjects who are fully vaccinated against SARS-CoV-2 may enroll.
- •5.Disseminated intravascular coagulation with active bleeding or signs of thrombosis.
- •6.History of prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
- •7.History of non-myeloid malignancy except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy (which may be continued while on study) and with normal prostate specific antigen for > 1 year prior to start of study therapy; or any other cancer that has been in complete remission without treatment for = 3 years prior to enrollment.
- •Note: Subjects who are on adjuvant hormonal therapy and = 3 years from definitive therapy for their primary tumor are eligible to enroll.
- •8.Current (within 30 days of study enrollment) drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •9.Ongoing (within 6 weeks of study enrollment) hepatic encephalopathy.
- •10.Treatment with proton pump inhibitors (PPIs) from 7 days prior to enrollment until 48 hours after completion of ENTO or placebo.
- •Note: PPIs are likely to interfere with ENTO absorption, thus requiring a 7-day washout period. H2 receptor antagonists and antacids are allowed for use during the study treatment period.
- •11.Ongoing immunosuppressive therapy, including systemic chemotherapy for treatment of leukemia.
- •Note: Subjects may not receive AML-directed therapy prior to enrollment other than hydroxyurea or leukapheresis for acute management of hyperleukocytosis.
- •12.Concurrent (within 14 days of study enrollment) participation in an investigational drug study with therapeutic intent.
- •13.Clinical signs/symptoms of leukostasis that have failed therapy including hydroxyurea and/or leukapheresis of at least 3 days duration.
- •14.Clinically significant heart disease defined as:
研究者
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