ACTRN12621000223831招募中2 期
Precision Medicine for Chronic Myelomonocytic Leukaemia in Adults: A phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Confirmed diagnosis of CMML, including t-CMML, satisfying the WHO 2016 criteria
- •2. Aged 18 or older
- •3. Cytopenia, constitutional symptoms or proliferative CMML (white blood cell count >=13
- •4. Detection of TET2 mutation or NRAS/KRAS/CBL mutation at a variant allele frequency
- •of >=3%. Participants who are found to have both TET2 and RAS pathway mutations will
- •be allocated to the lenzilumab/azacitidine arm of the study.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
- •6. Based on known non-CMML related medical history, expected to have a life
- •expectancy of >= 24 months.
- •7. Must have the following local laboratory results:
- •a. Liver function (total bilirubin <=1.5* x upper limit of normal [ULN], aspartate
- •aminotransferase [AST] and alanine aminotransferase [ALT] <=3 x ULN). For
- •participants with hepatomegaly due to extramedullary haematopoiesis, AST
- •and/or ALT must be < 5 x ULN. *For participants with total bilirubin >1.5 x ULN,
- •direct bilirubin must be <= ULN.
- •b. Kidney function: creatinine clearance >30 mL/min using Cockcroft-Gault formula.Note:
- •the Adjusted Body Weight formula should be used for participants with a BMI of = 30.
- •Actual Body weight should be used when BMI is < 30.
- •8. Ability to understand the requirements of the study and informed consent.
- •9. Reproductive status
- •a. Women of childbearing potential (WOCBP) must have a negative serum or urine
- •pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24
- •hours prior to the start of study drug
- •b. Women must not be breastfeeding
- •c. WOCBP must agree to follow instructions for method(s) of contraception for the
- •duration of treatment with study drug, plus 30 days (duration of ovulatory cycle) for a total of 30 days post-treatment completion
- •d. Men who are sexually active with WOCBP must agree to follow instructions for
- •method(s) of contraception for the duration of treatment with study drug plus 90
- •days (duration of sperm turnover) for a total of 90 days post-treatment
- •completion.
排除标准
- •1.Prior hypomethylating or intensive cytotoxic treatment for CMML except for
- •hydroxyurea. Hydroxyurea may be given prior to starting active protocol treatment
- •and during the first 14 days of Cycle 1 only
- •2.Prior treatment with an investigational agent, or radiotherapy within 28 days before
- •Cycle 1 Day 1 (or within 5 half-lives of the investigational agent, whichever is longer).
- •Participants must have recovered from the toxic effects of that therapy to <= Grade 1 or
- •baseline grade.
- •3.Major surgery within 2 weeks or having not recovered from surgery.
- •4. Treatment with G-CSF within 7 days of screening or GM-CSF within 28 days of
- •5.Serious medical or psychiatric illness likely to interfere with participation in this clinical
- •6.Other concurrent uncontrolled medical conditions. These include, but are not limited
- •to: uncontrolled diabetes, uncontrolled infections, acute or chronic liver and renal
- •disease, uncontrolled cardiovascular conditions, including ongoing cardiac arrhythmias
- •(e.g. ventricular arrhythmias or Torsades de Pointes, or third-degree heart block without
- •pace maker insertion) or uncontrolled congestive cardiac failure.
- •7.Myocardial infarction or clinically significant pericardial effusion within the past month.
- •8.Another primary malignant disease that requires active treatment. Basal or squamous cell skin carcinomas adequately treated are allowed.
- •9.Acute or chronic liver disease (including chronic hepatitis B and C infections). Hepatitis B Virus core antibody positivity is not an automatic exclusion.
- •10.Patients with known active Hepatitis A infection. Testing for Hepatitis A is not required as part of screening for this study.
- •11.Participants with known human immunodeficiency viruses (HIV). Screening for HIV is not required for this study.
- •12.Participants who are unable to comply with requirements for contraception as per study requirements.
- •13.Prior allogeneic stem cell transplantation.
- •14.Current participation in another therapeutic clinical trial (participation in clinical trials that do not involve active interventions is not an exclusion for the study).
研究者
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