EUCTR2014-002610-23-DE进行中（未招募）1 期
A Phase 1/2 Study of Venetoclax in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are = 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
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. 1. Subject must be = 65 years of age in Phase 1 and initial Phase 2.
- •Subjects enrolled in Phase 2 Cohort C must be either:
- •- = 75 years of age;
- •- = 60 to 74 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy:
- •o 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 (calculated by
- •Cockcroft-Gault formula);
- •o Moderate hepatic impairment with total bilirubin > 1.5 to = 3.0 ×ULN;
- •o Any other comorbidity that the physician judges to be incompatible
- •with intensive chemotherapy must be reviewed and approved by the
- •study medical monitor before study enrollment..
- •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 adequate renal function as demonstrated by a creatinine clearance = 30 mL/min; determined via urine collection for 24-hour creatinine clearance.
- •6. 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 for subjects who are < 75 years of age must have a bilirubin of < 3.0 × 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) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
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 venetoclax, as well as anticipated venetoclax 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:
- •? Strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.
- •6. 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.
- •7. 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.
- •8. Subject has a white blood cell count > 25 × 10 9/L. Note: Hydroxyurea is permitted to meet this criterion.
研究者
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