EUCTR2016-003900-30-ES进行中（未招募）1 期
A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 175
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
- •A subject will be eligible for study participation if he/she meets the following criteria within 21 days prior to randomization.
- •Subject must have histological confirmation of AML by WHO criteria, is ineligible for intensive induction chemotherapy and either is:
- •- = 75 years of age
- •- = 18 to 74 years of age and fulfill at least one criteria associated with lack of fitness for intensive induction chemotherapy:
- •o Eastern Cooperative Oncology Group (ECOG) Performance status of 2 – 3
- •o Cardiac history of CHF requiring treatment or Ejection Fraction = 50% or chronic stable angina
- •o DLCO = 65% or FEV1 = 65%
- •o Creatinine clearance = 30 mL/min to < 45 ml/min
- •o Moderate hepatic impairment with total bilirubin > 1.5 to = 3.0 × ULN
- •o Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrollment
- •Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status:
- •of 0 to 2 for subjects = 75 years of age OR
- •of 0 to 3 for subjects between 18 to 74 years of age
- •Subject must have a projected life expectancy of at least 12 weeks.
- •Subject must have adequate renal function as demonstrated by a creatinine clearance = 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection.
- •Subject must have adequate liver function as demonstrated by:
- •aspartate aminotransferase (AST) = 3.0 × ULN*
- •alanine aminotransferase (ALT) = 3.0 × ULN*
- •bilirubin = 1.5 × ULN*
- •o Subjects who are < 75 years of age may have bilirubin of = 3.0 × ULN
- •* Unless considered to be due to leukemic organ involvement.
- •Female subjects must be either postmenopausal defined as:
- •- Age > 55 years with no menses for 12 or more months without an alternative medical cause OR
- •- Age = 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L.
- •- Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •- A Woman of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
- •Male subjects who are sexually active, must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
- •Females of childbearing potential must have negative results for pregnancy test performed:
- •- At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
- •- Prior to dosing with urine sample obtained on Week 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
- •- Subject with borderline pregnancy tests at screening must have a serum pregnancy test = 3 days later to document continued lack of a positive result.
- •Subject must voluntarily sign and date an informed, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number
排除标准
- •Subject has received any prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Prior treatment for Myelodysplastic Syndrome is allowed except for use of cytarabine.
- •Subject had an antecedent myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, olycythemia vera, or chronic myelogenous leukemia (CML) with or without BCR-ABL mutation.
- •Subjects that have acute promyelocytic leukemia (APL).
- •Subject has known CNS involvement with AML.
- •Subject has known HIV infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax).
- •Subject is known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals (non-exclusionary medications) are not excluded.
- •Subject has received strong or moderate CYP3A inducers 7 days prior to the initiation of study treatment.
- •Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.
- •Subject has cardiovascular disability status of New York Heart Association Class > 2. Class 2 is defined as cardiac disease which subjects are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or angina pain.
- •Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.
- •Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.
- •Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
- •Subject has a history of other malignancies prior to study entry, with the exception of:
- •- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
- •- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- •- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- •Subject has a white blood cell count > 25 × 109/L. (Note: Hydroxyurea administration or leukapheresis is permitted to meet this criterion).
研究者
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