ACTRN12620000851965进行中（未招募）2 期
An Australasian Leukaemia and Lymphoma Group (ALLG) single arm phase II study to evaluate the efficacy of asciminib in newly diagnosed patients with chronic phase chronic myeloid leukaemia.
Australiasian Leukaemia and Lymphoma Group0 个研究点目标入组 101 人开始时间: 2020年8月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
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.Newly diagnosed CML-CP patients aged 18 or older
- •a)Prior ABP-TKI exposure greater than 14 days is not permitted.
- •i)Hydroxyurea or anagrelide treatment permitted prior to commencing asciminib (this may be continued for up to 1 week after commencing study treatment)
- •ii)Leukapheresis allowed as indicated
- •b)Must be equal to or less than 6 months from diagnosis to screening
- •c)Must have e13a2 and/or e14a2 transcript on screening BCR-ABL QPCR. Transcript e1a2 also permitted.
- •d)Must have bone marrow confirming chronic phase as per ELN (not WHO) criteria.
- •e)Additional cytogenetic abnormalities at baseline or diagnosis do not classify a patient as accelerated phase for the purpose of this study.
- •2.Willingly provide informed consent and agree to comply with study protocol
- •3.ECOG performance status 0-2
- •4.Based on known medical history, expected to have a life expectancy of greater thsn or equal to 12 months
- •5.Eligible for reimbursed treatment with imatinib, dasatinib or nilotinib under the PBS complex drug program in Australia, the Pharmac system in New Zealand, or through other arrangements with regulatory and funding authorities (compassionate supply or hospital funded supply).
排除标准
- •1.Major surgery within 2 weeks of, or having not recovered from surgery, by the time of screening.
- •2.Abnormal clinical laboratory results (re-screening allowed)
- •a)Total bilirubin greater than 1.5x ULN (in patients with Gilbert’s syndrome, total bilirubin greater than 3x ULN, or direct bilirubin greater than 1.5x ULN)
- •b)Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3x ULN.
- •c)Alkaline phosphatase greater than 2.5 times the ULN unless considered to be not of hepatic origin
- •d)Creatinine greater than 1.5 times ULN
- •e)Amylase / Lipase values greater than 1.5 times institutional ULN
- •3.Treatment with strong inducers of CYP3A4/5, CYP2C8 and CYP2C9 (See Appendix 1 for list of prohibited drugs). Consumption of grapefruit, Seville oranges, star fruit and their juice / derivatives / products is not permitted whilst a patient is taking study medication.
- •4.Active infection requiring systemic therapy at the time of screening
- •5.History of significant congenital or acquired bleeding disorder unrelated to cancer.
- •6.Known human immunodeficiency virus (HIV) positive (testing to exclude infection is not required in the absence of suggestive history)
- •7.Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •8.Corrected QT interval (QTc) of greater than 480 milliseconds (ms) on baseline electrocardiogram (ECG) (using corrected QT interval using Fridericia [QTcF]).
- •9.Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias (e.g. ventricular arrhythmias or Torsades de Pointe, or third degree heart block without pace maker insertion); congestive heart failure, angina, or myocardial infarction within the past 3 months prior to screening.
- •10.Other concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol.
- •11.Cytopathologically confirmed CNS infiltration. (In the absence of suspicion of CNS involvement, lumbar puncture is not required.)
- •12.A history of concomitant primary malignant disease that requires active cytotoxic treatment and / or a life limiting illness expected to have a life expectancy less than 5 years.
- •13.History of acute pancreatitis within 1 year of study entry, chronic pancreatitis, or any ongoing pancreatic disease.
- •14.Acute or chronic active liver disease. HBV core antibody positivity is not an automatic exclusion.
- •15.Subjects unable to comply with requirements for contraception as per study requirements.
- •16.Prior stem cell transplantation.
- •17.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. (See appendix 4)
- •e)Azoospermic males are exempt from contraceptive requireme
研究者
相似试验
招募中
不适用
Australasian Leukaemia and Lymphoma Group National Blood Cancer RegistrySuspected or Known or Diagnosed Blood CancerCancer - Leukaemia - Acute leukaemiaPublic Health - Health service researchCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaACTRN12612000337875Australasian Leukaemia and Lymphoma Group2,000
招募中
2 期
HL35: A study of Pembrolizumab And Chemo-Immunotherapy as FIrst-line therapy for patients with primary mediastinal B-Cell lymphoma.Primary mediastinal B-cell lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaACTRN12621001529831Australasian Lymphoma and Leukaemia Group35
招募中
不适用
Australian and New Zealand Lymphoma and Related Diseases RegistryymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaCancer - Leukaemia - Chronic leukaemiaLymphomaACTRN12617000050358Monash University8,000
已完成
不适用
MRC ALL 97 - UK national lymphoblastic leukaemia (ALL) trialeukaemiaLymphoblastic leukaemiaCancerISRCTN26727615Medical Research Council (MRC) (UK)1,800
已完成
不适用
Acute lymphoblastic leukaemia (ALL) trial XII (joint trial with Eastern Co-operative Oncology Group - E2993)eukaemiaCancerLeukaemiaISRCTN77346223Medical Research Council (MRC) (UK)550