Phase 1 Study of Venetoclax in Combination With Decitabine 10-Day Regimen in Subjects With Acute Myeloid Leukemia
概览
- 阶段
- 1 期
- 干预措施
- Decitabine
- 疾病 / 适应症
- Acute Myeloid Leukemia
- 发起方
- University of Chicago
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The rate of dose limiting toxicity (DLT)
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
The main purpose of this study is to learn about the safety and tolerability of an experimental drug, Venetoclax, when it is given along with Decitabine in subjects diagnosed with acute myeloid leukemia (AML).
研究者
入排标准
入选标准
- •Phase 1: Dose Escalation Phase
- •High risk AML, including any of the following:
- •Relapsed or refractory disease
- •TP53 mutant AML
- •Adverse risk cytogenetics including any of the following: 3 or more abnormalities; deletions involving chromosomes 5, 7, or 17; abnormalities in chromosome 11 involving MLL; t(6;9); inv(3) or t(3;3)
- •ECOG performance status 0-2
- •Age 18 years or older
- •Adequate organ function as defined by all of the following:
- •Creatinine clearance ≥30 mL/min, determined by the Cockroft-Gault formula, or measured by a 24 hour urine collection
- •AST and ALT ≤3 x ULN and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e. leukemic involvement).
排除标准
- •\- Key exclusion criteria (apply to both Phase 1 and Phase 2 portions of the study):
- •Concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol
- •Patients suitable for and willing to receive intensive induction chemotherapy
- •Use of investigational agents and/or anticancer therapy within 2 weeks of study entry (with the exception of hydroxyurea, which is permitted before and during Cycle 1 of therapy until D10, at the discretion of the investigator)
- •Prior treatment with venetoclax, decitabine, or azacitidine
- •Diagnosis of acute promyelocytic leukemia
- •Pregnant or breastfeeding patients
- •Patient known to be positive for HIV
- •Known CNS involvement with AML
- •Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
研究组 & 干预措施
Treatment
Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21 Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21 During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21
干预措施: Decitabine
Treatment
Cycle 1 of Treatment will be Decitabine days 1-10 plus Venetoclax ramp up on days 1-3 followed by Venetoclax target dose on days 4-21 Cycle 2 of Treatment will be Decitabine days 1-10 plus Venetcolax target dose days 1-21 During maintenance Decitabine on days 1-5 plus Venetoclax days 1-21
干预措施: Venetoclax
结局指标
主要结局
The rate of dose limiting toxicity (DLT)
时间窗: 24 months
Determine the rate of subjects who experience a dose limiting toxicity and the maximum tolerable dose
次要结局
- Levels of toxicity with combination regimen(24 months)
- Assessment of Overall Survival(24 months)