TWO-STAGE, TWO-ARM, OPEN-LABEL PHASE II STUDY OF VENETOCLAX IN COMBINATION WITH AZACYTIDINE IN ACUTE MYELOID LEUKEMIA PATIENTS SELECTED USING EX VIVO DRUG SENSITIVITY SCREENING - VenEx

HUS Helsinki University Hospital0 个研究点目标入组 94 人开始时间: 2019年10月22日最近更新: 2020年2月1日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 94

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1.Written informed consent
•2.Patients who present with one of the following (except acute promyelocytic leukemia)
•a.De novo or secondary AML patients who are non-fit for standard induction therapy (see below)
•b.Relapsed or refractory AML patients following at least 1 line of prior therapies (see below)
•3.Ex vivo sensitivity testing performed to assess venetoclax sensitivity
•a.Validation cohort: All participants are treated with venetoclax+azacitidine irrespective of the ex vivo screening results.
•b.Study cohort: Only the participants exhibiting ex vivo sensitivity to venetoclax are included to study therapy.
•4.Participant must have ECOG Performance status = 2 for participants = 75 years of age OR = 3 for participants = 18 to 74 years of age
•5.Leukocyte count < 25 x10E9/l. Hydroxyurea use is permitted to meet this criterion.
•6.Participant must have adequate renal function as demonstrated by a calculated creatinine clearance = 30 mL/min; determined by the Cockcroft Gault formula.
•7.Participant must have adequate liver function as demonstrated by
•a.alanine aminotransferase (ALT) = 4.0 × ULN
•b.bilirubin = 1.5 × ULN
•8. Specific inclusion criteria for participants non-fit for standard chemotherapy
•Participant must be:
•= 70 years of age;
•= 18 to 69 years of age and ineligible for intensive chemotherapy meeting at least one of the criteria following:
•Clinically significant comorbidities, as reflected by at least 1 of:
•-Left ventricular ejection fraction (LVEF) < 50%.
•-Lung diffusion capacity for carbon monoxide (DLCO) = 65% of expected.
•-Forced expiratory volume in 1 second (FEV1) = 65% of expected.
•-Chronic stable angina or congestive heart failure controlled with medication.
•-Alanine aminotransferase (ALT) 3.0-4.0 × ULN
•Other contraindication(s) to anthracycline therapy (must be documented)
•Adverse risk karyotype associated with poor outcome with standard chemotherapy
•Patient’s refusal from intensive chemotherapy
•9. Specific inclusion criteria for relapsed patients
•Participant must be:
•= 55 years of age with non-CBF AML relapse
•= 18 to 54 years of age and meeting at least one of the criteria following:
•Not candidate for intensive chemotherapy (see the criteria 8.)
•The duration of remission < 12 months.
•Relapse after allogeneic transplantation.
•2nd (or higher) relapse.
•10. Specific inclusion criteria for refractory patients
•The patients who fail to achieve a complete or partial remission after induction chemotherapy (two cycles of chemotherapy containing cytarabine or clofarabine, in compilation with topoisomerase II inhibitor (e.g. anthracycline or mitoxantrone)
•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 40

排除标准

•1.Participant has acute promyelocytic leukemia (APL)
•2.The leukemic cell content (blast percentage) in bone marrow/peripheral blood (depending which is used for drug sensitivity testing) is = 10 %
•3.ECOG >3 (see also inclusion criteria 4)
•4.Participant has known CNS involvement with AML (note: CSF or radiological investigations are not required without clinical suspicion)
•5.Participant with known HIV infection or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection that is not controlled with anti-viral medication.
•6.Participant has cardiovascular disability status of New York Heart Association Class = 2. Class 2 is defined as cardiac disease in which participants are comfortable at rest but ordinary physical activity results in palpitations, fatigue, dyspnea, or anginal pain.
•7.Evidence of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participation in this study (including but not limited to):
•a.Participant has a chronic respiratory disease that requires continuous oxygen use
•b.Systemic uncontrolled infection requiring therapy (viral, bacterial or fungal)
•c.Malabsorption syndrome or other condition that precludes enteral route of administration.
•d.Uncontrolled GVHD.
•8.Participant has a history of other malignancies prior to study entry, with the exception of previous malignancy treated with curative intent.

研究者

发起方

HUS Helsinki University Hospital

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