EUCTR2016-001466-28-SE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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 confirmation of AML by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities.
- •? Subject must be = 18 years of age.
- •? Subject must have a projected life expectancy of at least 12 weeks.
- •? Subject must be considered ineligible for induction therapy defined by the following:
- •- = 75 years of age; OR
- •- = 18 to 74 years of age with at least one of the following co-morbidities:
- •? ECOG Performance Status of 2 or 3;
- •? Cardiac history of CHF requiring treatment or Ejection Fraction = 50% or chronic stable angina;
- •? DLCO = 65% or FEV1 = 65%;
- •? Creatinine clearance = 30 mL/min to < 45 ml/min;
- •? Moderate hepatic impairment with total bilirubin > 1.5 to = 3.0 × ULN;
- •? Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie TA MD before study enrollment.
- •? Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status:
- •- 0 to 2 for subjects = 75 years of age OR
- •- 0 to 3 for subjects = 18 to 74 years of age.
- •? 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*
- •* Unless considered to be due to leukemic organ involvement
- •o Subjects who are < 75 years of age may have a bilirubin of = 3.0 × ULN
- •? Female subjects must be either postmenopausal defined as:
- •- Age > 55 years with no menses for 12 or more months without an alternative medical cause
- •- 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).
- •- Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control, starting at Study Day 1 through at least 90 days after the last dose of study drug.
- •? Male subjects who are sexually active, must agree, from Study Day 1 through at least 90 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 90 days after the last dose of study drug.
- •? Female subjects 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 Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
- •? Subject must voluntarily sign and date an informed consent, 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •? Subject has received treatment with the following:
- •- A hypomethylating agent, venetoclax and/or chemo therapeutic agent for Myelodysplastic syndrome (MDS).
- •- CAR-T cell therapy
- •- Experimental therapies for MDS or AML.
- •-Current participation in another research or observational study.
- •? Subject has history of myeloproliferative neoplasm (MPN).
- •? Subject has the following:
- •- Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;;17) as per the NCCN Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
- •? Subject has acute promyelocytic leukemia
- •? Subject has known active CNS involvement with AML.
- •? Subject has known HIV infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax) HIV testing will be performed at
- •Screening, only if required per local guidelines or institutional standards.
- •? Subject is known to be positive for hepatitis B or C infection [HCV Ab indicative of a previous or current infection; and/or positive HBs Ag or detected sensitivity on
- •HBV-DNA PCR test for HBc Ab and/or HBs Ab positivity] with the exception of those with an undetectable viral load within 3 months of screening. (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV [i.e., HBs Ag-, and anti-HBs+] may participate.
- •? Subject has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
- •-Chinese AML subjects participating in the safety cohort per Appendix K are also excluded from receiving strong and/or moderate CYP3A inhibitors from 7 days prior to the initiation of study treatment through the entire dose limiting toxicity (DLT)/safety evaluation period.
- •? 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.
- •? Subject has a cardiovascular disability status of New York Heart Association Class > 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal 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 within 2 years 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 ;requires discussion with TA MD.
- •? Subject has a white blood cell count > 25 × 109/L. (Hydroxyurea or leukapheresis are permitted to meet this criterion.)
研究者
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