A Phase 1/2 Study of ABT-199 in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are = 65 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 67 人开始时间: 2014年10月2日最近更新: 2018年11月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AbbVie Deutschland GmbH & Co. KG
入组人数: 67

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

性别: All

入选标准

•1. Subject must be = 65 years of age.
•2. Subject must have a projected life expectancy of at least 12 weeks.
•3. Subject must have histological confirmation of AML and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
•4. Subject must have received no prior treatment for AML with the exception of hydroxyurea, allowed through first cycle of treatment. NOTE: Subject may have been treated for prior Myelodysplastic Syndrome.
•5. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
•6. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance = 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
•7. Subject must have adequate liver function as demonstrated by: aspartate aminotransferase (AST) = 2.5 × ULN*, alanine aminotransferase (ALT) = 2.5 × ULN*, bilirubin = 1.5 × ULN*, Unless considered due to leukemic organ involvement.
•Note: Subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN per discussion between the investigator and AbbVie medical monitor.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 67

排除标准

•1. Subject has received treatment with cytarabine for a pre-existing myeloid disorder.
•2. Subject has acute promyelocytic leukemia .
•3. Subject has known active CNS involvement with AML.
•4. Subject has tested positive for HIV (due to potential drug-drug interactions between antiretroviral medications and ABT-199, as well as anticipated ABT-199 mechanism-based lymphopenia that may potentially increase the risk of opportunistic infections). Note: HIV testing is not required.
•5. Subject has received the following within 7 days prior to the initiation of study treatment:
•Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's Wort;
•Warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect).
•6. Subject has received the following within 5 days prior to the initiation of study treatment:
•CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin.
•7. Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
•8. Subject has a cardiovascular disability status of New York Heart Association Class = 2. Class 2 is defined as cardiac disease in which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
•9. Subject has a white blood cell count > 25 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.

研究者

发起方

AbbVie Deutschland GmbH & Co. KG

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