ACTRN12616000445471招募中1 期
A phase Ib clinical evaluation of Venetoclax in combination with chemotherapy in older patients with Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. De novo, secondary or therapy-related AML (except Acute Promyelocytic Leukaemia) without prior exposure to induction chemotherapy (not including hydroxyurea, low-dose cytarabine eg ~20mg bd, hypomethylating agents or non-chemotherapy-based investigational agents)
- •2. Age greater than or equal to 65
- •3. Or Age greater than or equal to 60 and monosomal karyotype
- •4. ECOG performance status 0-1
- •5. Adequate hepatic function as defined by bilirubin less than or equal to 1.5 x the upper limit of normal (ULN, excluding Gilbert’s syndrome) and AST & ALT less than or equal to 2.5 x ULN (unless due to leukemic involvement)
- •6. Adequate renal function as defined by eGFR>50ml/min as assessed by eCCr =(140 – Age) x (Weight in kg) x [1.23 if Male, 1.04 if Female]/Serum Creatinine (micromol/L)
- •7. WCC less than 25 x 109/L (hydroxyurea allowable to reduce WCC prior to day 1 of study)
排除标准
- •1. Prior investigational anti-leukemia agents within 14 days of day 1 of study drug; demethylating agents within 14 days of day 1 of study drug; and hydroxyurea within 24 hrs prior to day 1 of study drug.
- •2. Prior exposure to Venetoclax or other BCL2 inhibitors
- •3. Prior anthracycline exposure for previous cancer
- •4. Any serious medical condition which the investigator feels may lead to an unacceptably high risk of treatment related death from 5+2 induction
- •5. Concurrent malignancy likely to affect treatment safety or study procedures
- •6. Known HIV infection
- •7. Uncontrolled viral hepatitis type B or C
- •8. Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the date of last dose
- •9. Cardiac ejection fraction <45%
- •10. 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).
- •11. Subject has received the following within 5 days prior to the initiation of study treatment:
- •* CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin.
- •12. 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.
- •13. Subject has a history of other malignancies prior to study entry, with the exception of:
- •*Adequately treated in situ carcinoma of the breast or cervix uteri;
- •*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.
- •*Prior malignancy treated >4 years ago and no evidence of active disease
研究者
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